xZrJ]e7,[Uv%d|7@$$! *Data on file. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 13,8750 - 99 pieces - 8,75100 - 200 pieces - 7,86more than 200 pieces - please contact us for a new quote. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. 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. PDF Document Title: Visual and Cosmetic Standards for Manufacturing 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. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. Height 25cm, diameter 7cm - Volume: 500 ml. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. We do not practice medicine or provide medical services or advice as a part of this website. Disc space preparation 5. Expected delivery: 3 weeks. Login - NuVasive Company Store - Direct EDJE The subject Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. Surgical efficiency meets reliable versatility. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. 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). Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; NuVasive Inc Company Profile - GlobalData Rethink how you buy and sell surgical supplies. Prices excluding VAT and shipping. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| UPDATE: Potential Concerns with NuVasive Precice Devices BOX8-1Five Key Steps for Performing the XLIF Procedure 1. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. All rights reserved. multi-level pathologies. Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. Expected delivery: 2 weeks. 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. Malone, H., Mundis, G. M., Jr., Collier, M, et al. %PDF-1.4 % Excluding VAT and shipping. Expected delivery: 3 weeks. All Trademarks referred to are the property of their respective owners. Eastlack and Mundis as they discuss, Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion?, recently published in the Journal of Neurosurgery Spine. NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasives results to differ materially from historical results or those expressed or implied by such forward-looking statements. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Alignment. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. The .gov means its official.Federal government websites often end in .gov or .mil. Intelligently designed for fusion. Retroperitoneal access 3. NuVasive is the fastest growing, full-line spine company. The store will not work correctly in the case when cookies are disabled. We are excited about the opportunities this acquisition creates as we work to optimize the surgeon experience, advance the standard of care, and create value for shareholders.. Duan R, Barbieri D, Luo X, et al. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. WestCMR does not provide advice, training, or clinical support. List of devices made by the manufacturer NUVASIVE, INC. 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. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto An integrated technology platform to enable better spine surgery. Product Code: NKB, KWP, MNI, MNH, KWQ C. Predicate Devices The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the PreceptTM (K1025 14), Armada (K092287), and SplzeRx PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. Our Standards: The Thomson Reuters Trust Principles. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. NUVASIVE: 2012022 SKU# 2012022-WE1. Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. 888 0 obj <>stream 'VUJ)(h. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC.
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