The NuVasive TLIF philosophy, coupled with its comprehensive portfolio, provides open and MAS procedural systems that include the requisite tools surgeons need to plan surgery, access affected levels, restore alignment and disc height, provide optimized fixation, and deliver graft material. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. For care of patients who currently have one of these devices and weigh less than 50 pounds and/or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. The materials on this website are for your general educational information only. endstream endobj startxref The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. NuVasive is the fastest growing, full-line spine company. An integrated technology platform to enable better spine surgery. If so, do not buy this item unless you are an authorized purchaser. Investor Conference Call Forward-Looking Statements For the best experience on our site, be sure to turn on Javascript in your browser. For the best experience on our site, be sure to turn on Javascript in your browser. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. The FDA continues to work with NuVasive to: The FDA will continue to keep health care providers and the public informed as new or additional information becomes available. Information you read on this website cannot replace the relationship that you have with your healthcare professional. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. endif; ?> Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? 1.0 Purpose. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Three New Biologic Products for Spine Surgery. Alignment. The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. Please close the page and access the Company Store via Okta. $1,299.99. Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P Globus, which is a provider of implantable devices and instruments used in spinal and orthopedic surgeries, made an indicative cash-and-stock offer for NuVasive in recent weeks, the sources said. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream All rights reserved. In an effort to evolve the standard of care for early-onset scoliosis (EOS) and adolescent deformity patients, we have invested in a comprehensive product portfolio that introduces surgical efficiencies and optimized implant constructs, and we remain committed to supporting the progression of clinical education and scientific research in this space. $749.00. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. 2020 - As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. *Data on file. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! Transaction Details San Diego, California 92121 Re: K210214 Trade/Device Name: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Reimagine cervical spine surgery. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Spine 2020;45(14):944-51. Make sure cookies are enabled in your browser. PDF NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs System Headquarters United States of America. Biologics - NuVasive NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. Photos are for illustration purposes only and may not depict the exact item. Osteocel is human tissue donated specifically for human clinical use. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. Transpsoas access 4. The contents of this Site, including but not limited to the text and images herein and their arrangements, unless otherwise noted, are the copyrighted material of Oisto. You have not been assigned a username and password. NuVasive provides patient support and surgeon education. Forward-looking statements include, but are not limited to, statements about the potential benefits of the acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. PLoS ONE 2011;6(10):1-8. Information you read on this website cannot replace the relationship that you have with your healthcare professional. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. PDF NuVasive, Incorporated March 25, 2020 - Food and Drug Administration By using modern education principles, competency-based curriculum, and multi-modal learning pathways, the CPD team and its dedicated surgeon faculty provide an unparalleled learning experience for surgeons and their staff around the globe. The integration of XLIF, XALIF, and XFixation into a single platform enables surgeons to treat a patient without repositioning, which may reduce patient time under anesthesia and hospital costs. Intelligently designed for fusion. At NuVasive, we transform surgery, advanced care, and change lives. All products | NuVasive Webshop %%EOF In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. Copyright 2022 Oisto. var site_url = "https://www.medicaldevices24.com/"; D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (TI-SI). Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. Information you read on this website cannot replace the relationship that you have with your healthcare professional. Alignment Matters . Innovation in Musculoskeletal Solutions | Globus Medical hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl The materials on this website are for your general educational information only. Evaluate additional biocompatibility assessments intended to address specific biocompatibility concerns with all Precice devices and collect additional data to better understand the risks to patients. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. 50 - 99 pieces - 8,75. This power bank is suitable for charging any device. NuVasive Company Profile - Office Locations, Competitors, Revenue The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto NUVASIVE: 2012022 SKU# 2012022-WE1. NuVasive is the fastest growing, full-line spine company. The Sage Lateral Plate System Pursuant to the terms of the transaction agreement, NuVasive made an upfront payment to Simplify Medical of $150.0 million at closing, subject to customary purchase price adjustments, and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Cervical Artificial Disc technology. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. Implant insertion Excluding VAT and shipping. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. Home | NuVasive Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. NuVasive is the fastest growing, full-line spine company. Plenty of storage and clever organisation for life on the go, Store a 15.6" laptop in the dedicated compartment padded with EVA Impact Foam for extra protection, Spacious main compartment with structured slip pockets for a tablet, For organising a portable charger, cables and accessories, Lightweight collapsible pitchfork made of high-quality ABS plastic, Equipped with a magnetic ball marker with Nuvasive logo-doming, Kobaldeck playing cards are of absolute top quality, Back of cards and box are printed with Nuvasive logo, Receptacles for Europe, USA/Japan, Australia/China, All international security-relevant standards and norms, Keeps your drinks cold for 8 hours and hot for 5, Height 25cm, diameter 7cm - Volume: 500 ml, Ergonomic design provides a comfortable fit for your ears, Handy pocket-size power booster - 5000mah. At NuVasive, we transform surgery, advanced care, and change lives. On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices. Excluding VAT and shipping. PDF NVM5 Computer-Assisted Rod Bending Peer-to-peer discussion between Drs. Open the catalog to page 2 What is causing my pain? westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. Leading Independent Proxy Advisory Firm Glass Lewis Joins ISS in Recommending NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, Leading Independent Proxy Advisory Firm ISS Recommends NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, NuVasive to Participate in Upcoming Global Spine Conferences, NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients. The X360 System is a comprehensive approach to lateral single-position surgery powered by Surgical Intelligence, an ecosystem of technologies enabling safer, faster, smarter surgery. An official website of the United States government, : gtag('js', new Date()); Address 7475 Lusk Blvd, San Diego, California, 92121. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. List of devices made by the manufacturer NUVASIVE, INC. PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory NV Dynamic Stimulation Clip and Inline Activator. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. All rights reserved. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. SAN DIEGO February 24, 2021 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it has acquired Simplify Medical, a privately held company and developer of the Simplify Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR). As of date of publication, March 2017; data on file. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. List of devices made by the manufacturer NUVASIVE, INC. NuVasive is developing the operating room of the future. ET / 1:30 p.m. PT to discuss these results. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. You should always talk to your healthcare professional for diagnosis and treatment. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. NuVasive, 8050015, NuVasive NVM5 EMG Needle Module - eSutures Simplify Medical is located in Sunnyvale, California. NuVasive logo printed in 1 colour Prices (minimum order quantity 10 pieces) 10 - 24 pieces - 22,65 25 - 49 pieces - 19,30 50 - 100 pieces - 17,60 more than 100 pieces - please contact us for a new quote. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. The SRS-Schwab adult spinal deformity classification: Retroperitoneal access 3. Excluding VAT and shipping. December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics' Precice devices made from. Excluding VAT and shipping. 2. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from stainless steel and titanium. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to . Price: $5.00 per kit. NuVasive offers solutions to alleviate patient symptoms. 1. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. var base_url = "https://www.medicaldevices24.com/"; NuVasive Launches Next-Gen Reline Spine Fixation System San Diego, CA 92121 PCM THE CERVICAL DISC SYSTEM INSTRUCTIONS FOR USE Rx Only GRAPHICAL SYMBOLS Read Instructions Before Use Single Use Only Catalog Number Lot Number STLE RSterile by Irradiation Non-Sterile, Sterilize by Steam before Use Manufacturer Use By HOW SUPPLIED Prices excluding VAT and shipping. You should always talk to your healthcare professional for diagnosis and treatment. 888 0 obj <>stream Get your money back!. Becoming the number one partner in pediatrics. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. 'VUJ)(h. We do not practice medicine or provide medical services or advice as a part of this website. Based on review of publicly available materials at the time of this release. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to its C360 portfolio. Expected delivery: 3 weeks. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. Learn more about the value of Biologics Information you need When fusion is recommended window.dataLayer = window.dataLayer || []; All Trademarks referred to are the property of their respective owners. D. Device Description. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life. PDF San Diego, CA 92121 PCM - Food and Drug Administration 8050015: NuVasive NVM5 EMG Needle Module. Robert Eastlack and Gregory Mundis. PDF eXtreme - SMISS Simplify Medicals technology was designed to offer surgeons best-in-class capabilities for cTDR across key performance functions, including: NuVasive will leverage its commercial and distribution channels in the U.S. and international markets to drive utilization of the Simplify Disc. All products sold by WestCMR are in-date. xZrJ]e7,[Uv%d|7@$$! Unhappy? Expected delivery: 2 weeks. NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121 Re: K191974 Trade/Device Name: NuVasive AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV The acquisition of Simplify Medical advances our previously communicated long-term growth strategy by both expanding, and further distinguishing, our portfolio with industry-leading innovation, said J. Christopher Barry, chief executive officer of NuVasive. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. 1Simplify Cervical Artificial Disc P200022. D. Device Description Prices(minimum order quantity 25 pieces)25 - 49 pieces - 17,7550 - 99 pieces - 15,90100 - 150 pieces - 14,70more than 150 pieces - please contact us for a new quote. Product images are for display only. NuVasive Inc Company Profile - GlobalData This is why we show up every day, united and committed to our vision. The store will not work correctly in the case when cookies are disabled. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to help transform spine surgery, and ultimately change the lives of your patients. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. Adhering to the three core principles of Advanced Materials ScienceSurface, Structure, and ImagingNuVasive has pioneered design and manufacturing methods that combine the inherent benefits of porosity with the advantageous material properties of PEEK and titanium to create implants intelligently designed for fusion. UPDATE: Potential Concerns with NuVasive Precice Devices COCCYX ZONE OF SPINE FOR. NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. function gtag(){dataLayer.push(arguments);} COMPANY CONFIDENTIAL. Product Code: LLZ C. Predicate Devices The subject NuVasive NuvaLine is substantially equivalent to the primary predicate NuVasive NuvaLine Mobile App (K162647) and additional reference devices NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus Image Mangement System (K171130). $650.00. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. The industry leader for online information for tax, accounting and finance professionals. NuVasive funded the upfront payment at closing using available cash on hand. CODE: NS10000565. Disc space preparation 5. Journal of Neurosurgery Spine. JavaScript seems to be disabled in your browser. Combining the Simplify Disc with NuVasives C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. NuVasive is developing the operating room of the future. Expected delivery: 3 weeks. DLA Piper is serving as NuVasives legal counsel. ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. Three New Biologic Products for Spine Surgery The website is intended to provide information that might be of interest to users. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. About Simplify Medical (This story corrected name of Globus Medical in the headline from Global Medical). Returns are simple. 789 0 obj <> endobj devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). You don't have to face this journey alone. %PDF-1.5 % Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. At NuVasive, we transform surgery, advanced care, and change lives. We do not practice medicine or provide medical services or advice as a part of this website. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. 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