Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. 2.0 Scope One position. 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. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. Voluntary reports can be submitted through, Device manufacturers and user facilities must comply with the applicable, Health care personnel employed by facilities that are subject to the. Retroperitoneal access 3. An official website of the United States government, : 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. 3. 50 - 99 pieces - 8,75. List of devices made by the manufacturer NUVASIVE, INC. 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. 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 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. 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. if( $robots ) : ?> 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. NuVasive is the fastest growing, full-line spine company. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. 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. Before sharing sensitive information, make sure you're on a federal government site. All Trademarks referred to are the property of their respective owners. NuVasive offers solutions to alleviate patient symptoms. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. Read the press release Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. All rights reserved. Excluding VAT and shipping. 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. Transpsoas access 4. NuVasive is developing the operating room of the future. The materials on this website are for your general educational information only. You should always talk to your healthcare professional for diagnosis and treatment. DLA Piper is serving as NuVasives legal counsel. Thu, October 4th, 2018. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. Disc space preparation 5. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. Intelligently designed for fusion. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. We do not practice medicine or provide medical services or advice as a part of this website. Get your money back!. 1. Please close the page and access the Company Store via Okta. Spine 2020;45(14):944-51. Quantity: 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. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. The materials on this website are for your general educational information only. 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. 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. 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 For the best experience on our site, be sure to turn on Javascript in your browser. Information you read on this website cannot replace the relationship that you have with your healthcare professional. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. 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. NV Dynamic Stimulation Clip and Inline Activator. You don't have to face this journey alone. Implant insertion It will also discuss the Simplify Medical transaction at that time. 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. We do not practice medicine or provide medical services or advice as a part of this website. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. 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. Reimagine cervical spine surgery. 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. The subject NUVASIVE: 2012022 SKU# 2012022-WE1. Prices(minimum order quantity 10 pieces)10 - 24 pieces - 22,6525 - 49 pieces - 19,3050 - 100 pieces - 17,60more than 100 pieces - please contact us for a new quote.Expected delivery: 3 weeks. Height 25cm, diameter 7cm - Volume: 500 ml. NuVasive Launches Modulus ALIF. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. xZrJ]e7,[Uv%d|7@$$! Photos are for illustration purposes only and may not depict the exact item. All quotes delayed a minimum of 15 minutes. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Expected delivery: 3 weeks. 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. An integrated technology platform to enable better spine surgery. 'VUJ)(h. Peer-to-peer discussion between Drs. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. You should always talk to your healthcare professional for diagnosis and treatment. 1Simplify Cervical Artificial Disc P200022. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. $650.00. NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined companys products and technologies; and the risk that benefits from the acquisition may not be fully realized or may take longer to realize than expected. from FortisBC Holdings Inc for C$400 million ($294.68 million). Based on review of publicly available materials at the time of this release. 789 0 obj <> endobj Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. %%EOF hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl The SRS-Schwab adult spinal deformity classification: If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). Duan R, Barbieri D, Luo X, et al. The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. 1997-2023 WestCMR. Investor Conference Call PLoS ONE 2011;6(10):1-8. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. *Data on file. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. 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 Osteocel is human tissue donated specifically for human clinical use. Excluding VAT and shipping. 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. Three New Biologic Products for Spine Surgery. Our Standards: The Thomson Reuters Trust Principles. 8050015: NuVasive NVM5 EMG Needle Module. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. CODE: NS10000565. Copyright 2022 Oisto. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. All rights reserved. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine.
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