Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. It will also discuss the Simplify Medical transaction at that time. Osteocel provides a complete and physiologic bone graft that contains all of the necessary components for bone growth: the cells, the signals, and the scaffold. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- *Data on file. As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. 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. You should always talk to your healthcare professional for diagnosis and treatment. 1Simplify Cervical Artificial Disc P200022. You should always talk to your healthcare professional for diagnosis and treatment. 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. In this video, they review the findings around improved patient outcomes and reduced economic burden when using these products together. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. The potential combination would accelerate consolidation in the spine surgery market, where smaller players are turning to dealmaking to compete against the likes of Johnson & Johnson (JNJ.N), Medtronic Plc (MDT.N) and Zimmer Biomet Holdings Inc (ZBH.N). 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. The Instructions for Use for titanium-based Precice devices have been updated to include: For Titanium-Based Precice devices (Precice IMLL, Precice Short, Precice Freedom, Precice Unyte): Note: Stainless steel-based Precice devices remain recalled from the U.S. market. Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. NuVasive provides patient support and surgeon education. Clinical benefits ALIF Anterior approaches, such as in ALIF, allow access to the discs at the front of the spine and do not require muscle stripping as in posterior approaches. Alignment. NuVasive, 8050015, NuVasive NVM5 EMG Needle Module - eSutures -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| Elizabeth Hofheinz, M.P.H., M.Ed. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. Simplify Cervical Artificial Disc provides NuVasive most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment, Expands growth opportunities and further differentiates Companys comprehensive portfolio across ACDF, PCF, and cTDR procedures. All products | NuVasive Webshop It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. Osteocel is human tissue donated specifically for human clinical use. The store will not work correctly in the case when cookies are disabled. As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. Prices excluding VAT and shipping. At NuVasive, we aspire to change a patients life every minute. 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. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230). PDF San Diego, CA 92121 PCM - Food and Drug Administration An official website of the United States government, : In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. Learn how intelligent surgery can change your practice. PDF eXtreme - SMISS PDF NuVasive, Incorporated Ms. Daniela Mahan, Esq., RAC 7475 Lusk Blvd 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. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. 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 Three New Biologic Products for Spine Surgery BOX8-1Five Key Steps for Performing the XLIF Procedure 1. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? Robert Eastlack and Gregory Mundis. Following the commercial launch of the NuVasive ACP system and the Simplify Cervical Disc, we have recently introduced a posterior cervical fusion solution, Reline Cervical. 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. NuVasive provides patient support and surgeon education. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Lehr MA, Oner CF, Delawi D, et al. Make sure cookies are enabled in your browser. NuVasive is now able to address all key segments of the cervical spine by offering comprehensive, procedurally integrated solutions across anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), and cTDR procedures. DLA Piper is serving as NuVasives legal counsel. Excluding VAT and shipping. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. Thu, October 4th, 2018. 2.0 Scope Implant insertion This service located at Oisto.com is a website owned and operated by Oisto. Journal of Neurosurgery Spine. Excluding VAT and shipping. Information you read on this website cannot replace the relationship that you have with your healthcare professional. One position. Fusion is a surgical procedure in which one or more of the vertebrae of the spine are joined together (fused) so that motion no longer occurs between them. WestCMR does not provide advice, training, or clinical support. List of devices made by the manufacturer NUVASIVE, INC. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. Returns are simple. The subject At NuVasive, we transform surgery, advanced care, and change lives. About NuVasive The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 Do not implant more than two devices in a patient at once. NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. NuVasive Acquires Simplify Medical - NuVasive Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. We believe in the importance of preoperative decision-making and support toolsinformed by data and clinical experiencepaired with novel, intraoperative tools to execute a surgeon-specific plan. Neurostimulators & Components. About Simplify Medical 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. Retroperitoneal access 3. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto Excluding VAT and shipping. NuVasive has struggled with the impact that healthcare staffing shortages and weaker demand for elective surgery have had on its sales since the onset of the COVID-19 pandemic. devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. Expected delivery: 3 weeks. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Nov 15 (Reuters) - Globus Medical Inc (GMED.N) has approached NuVasive Inc (NUVA.O), a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar with the matter said.
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