The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. Robert Eastlack and Gregory Mundis. 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. As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasives focus on outcome-driven innovation, said David Hovda, president and chief executive officer of Simplify Medical. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. 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. 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. D. Device Description. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. $650.00. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. At NuVasive, we transform surgery, advanced care, and change lives. Excluding VAT and shipping. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. iMedSales is a premier surgical and medical equipment supplier that provides a combina Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~, Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image, STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG, Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill, Karl Storz 22220154 HD Image 1 H3M Microscope, Dr 3-Chip Camera, Karl Storz 20132020 Xenon Light Source 175 Watt ~ Lamp only has 13 hours, Medical Blue Nitrile Gloves Latex Free, Powder Free, Textured, Disposable, Non-Sterile 100 pieces per box of 1. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. 2Data on file. *Data on file. Please close the page and access the Company Store via Okta. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. Excluding VAT and shipping. At NuVasive, we aspire to change a patients life every minute. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. One comprehensive system. Telephone 1 858 9091800. Information you read on this website cannot replace the relationship that you have with your healthcare professional. 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. At NuVasive, we transform surgery, advanced care, and change lives. All products sold by WestCMR are in-date. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. 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 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. It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. 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. var base_url = "https://www.medicaldevices24.com/"; The Companys comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. 3. or more while undergoing treatment, and. 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. 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). Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. Get your money back!. All rights reserved. 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. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. COMPANY CONFIDENTIAL. var site_url = "https://www.medicaldevices24.com/"; The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. 1997-2023 WestCMR. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. It will also discuss the Simplify Medical transaction at that time. Expected delivery: 3 weeks. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. Malone, H., Mundis, G. M., Jr., Collier, M, et al. Address 7475 Lusk Blvd, San Diego, California, 92121. At NuVasive, we transform surgery, advanced care, and change lives. 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. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. DLA Piper is serving as NuVasives legal counsel. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f NuVasive offers solutions to alleviate patient symptoms. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. NuVasive offers solutions to alleviate patient symptoms. This power bank is suitable for charging any device. endstream endobj startxref One position. Expected delivery: 3 weeks. NuVasive is developing the operating room of the future. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. Learn how intelligent surgery can change your practice. 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. 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). NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. 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. The SRS-Schwab adult spinal deformity classification: Peer-to-peer discussion between Drs. An official website of the United States government, : An integrated technology platform to enable better spine surgery. 50 - 99 pieces - 8,75. The San Diego, CA-based company said the RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce . The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). 2.0 Scope 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. This service located at Oisto.com is a website owned and operated by Oisto. Open the catalog to page 2 What is causing my pain? Surgical efficiency meets reliable versatility. Information you read on this website cannot replace the relationship that you have with your healthcare professional. gtag('js', new Date()); Propel DBM Putty Plus and Gel Plus contain added cancellous chips and serve as a bone graft extender (extremities, posterolateral spine, pelvis) and bone void filler of the extremities and pelvis. Elizabeth Hofheinz, M.P.H., M.Ed. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. We do not practice medicine or provide medical services or advice as a part of this website. Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. The discussions between the companies are preliminary and there is no certainty that a deal will be reached, the sources added, requesting anonymity because the matter is confidential. NuVasive provides patient support and surgeon education. 809 0 obj <>/Filter/FlateDecode/ID[]/Index[789 100]/Info 788 0 R/Length 99/Prev 1608803/Root 790 0 R/Size 889/Type/XRef/W[1 2 1]>>stream obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. JavaScript seems to be disabled in your browser. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Alignment Matters . Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. gtag('config', 'G-XBG07ECKJ5'); BOLTS FOR SMALL CAGE COROENT INTERLOCK NUVASIVE, CERVICAL DISC PROSTHESIS CERPASS NUVASIVE, CONNECTOR AND NUT CLOSURE STERILE - VUEPOINT II, COROENT CAGE SMALL SCREW INTERLOCK NUVASIVE, COROENT LARGE OBLIQUE STERILE - CAGE INTERSOMATICO, COROENT SMALL INTERLOCK II - CAGE INTERBODY, COROENT XL TITANIUM BARREN - CAGE INTERBODY, DYNAMIC STIMULATION AND INLINE CLIP APPLICATOR, HOOK AND NUT CLOSURE STERILE - VUEPOINT II, LIVES FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, NV M5 XLIF KIT WIRE KIRSCHNER AND DILATOR, SCREWS E NUT CLOSURE STERILE - VUEPOINT II, STAPLE FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, SYSTEM COROENT XL STERILE - CAGE INTERBODY, THE PAS-II PEDICLE INSULATED SYSTEM ACCESS, Complete classification of medical devices. Expected delivery: 3 weeks. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Website www.nuvasive.com. PLoS ONE 2011;6(10):1-8. Reline 3D, which is an extension to the NuVasive's Reline system, is part of the firm's comprehensive spine fixation portfolio that includes Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. Returns are simple. 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. Unhappy? The unique microarchitecture of Attrax drives the differentiation of mesenchymal stem cells (MSCs) into bone-forming osteoblasts without added growth factors.2 The optimized microarchitecture of Attrax is engineered using tightly controlled parameters for a defined micropore size distribution within 0.3 to 1.1 microns, demonstrated to initiate greater bone formation compared to traditional ceramics.3, Attrax Putty is one of only a few bone grafting devices on the market supported by a Level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.4. List of devices made by the manufacturer NUVASIVE, INC. The store will not work correctly in the case when cookies are disabled. 8050015: NuVasive NVM5 EMG Needle Module. Forward-Looking Statements Polini A, Pisignano D, Parodi M, et al. The Simplify Disc is supported by level-1 evidence through the FDA investigational device exemption (IDE) study1 and was found to be clinically superior to ACDF in the randomized controlled trial. 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. Biomater Sci 2018;6:136-45. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. NuVasive provides patient support and surgeon education. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. Rethink how you buy and sell surgical supplies. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. Product images are for display only. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. 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. Implant insertion Exclusive news, data and analytics for financial market professionals, Reporting by Greg Roumeliotis in New York, US FDA declines to approve Ascendis' hormone disorder therapy, Astellas Pharma buys Iveric Bio for $5.9 billion, Pfizer, BioNTech propose EU pays half for each cancelled COVID dose, Financial Times reports, Indian cough syrup: mystery middleman may be new clue, Enbridge acquires gas storage facility in British Columbia for $295 million, Adani-owned NDTV profit plunges about 98% on weak advertising demand, U.S. FAA opens new direct plane routes ahead of summer travel, Russia temporarily halts gas supply to Armenia for planned maintenance, Norwegian Cruise lifts profit forecast on higher ticket prices, steady demand. hb```b````e`ad@ A(GcG!O HW7o.[S.8{bZx{f(*m(!$ d9>k=ggx rM},(qS>gz}":IHH]1s1@lL j,l l@6kzGkFGkfTt4E# `(AokavH8XVh|Pi\P(d. 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. 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. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. 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. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! $1,299.99. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. Globus Medical Inc has approached NuVasive Inc , a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar . The industry leader for online information for tax, accounting and finance professionals. xZrJ]e7,[Uv%d|7@$$! Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. That no more than two devices should be implanted at a time. 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. NuVasive funded the upfront payment at closing using available cash on hand. 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 NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. Previously, on April 5, 2021, NuVasive had posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. multi-level pathologies. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. 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.. 0 if( $robots ) : ?> About NuVasive NuVasive is the fastest growing, full-line spine company. The website is intended to provide information that might be of interest to users. Alignment. Reimagine cervical spine surgery. 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. 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.
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