clearance
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Hospitals
K2M Enhances PYRENEES(R) Product Family With the Addition of Its Mono Cervical Plate System
LEESBURG, Va., Sept. 3, 2015 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global medical device company…
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Xtant Medical receives FDA clearance for demineralized bone matrix putty: 4 observations
By Anuja Vaidya Xtant Medical’s wholly owned subsidiary Bacterin has received FDA 510(k) clearance of its OsteoSelect PLUS Demineralized Bone Matrix Putty.…
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Hospitals
Study: Breakthrough med devices slower to market than blockbuster drugs
By Fink Densford Medical device companies producing pioneering medical technology have a much longer, more expensive road to travel to…
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Hospitals
BioElectronics seeks US FDA marketing nod for ActiPatch therapy to treat musculoskeletal pain & edema
BioElectronics Corporation, maker of consumer medical electronics products for pain management, announced the filing of a 510(k) premarket notification for…
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Hospitals
VEXIM Initiates International Clinical Study
Toulouse, 4th June 2015 – VEXIM (FR0011072602 – ALVXM / EligiblePEA-PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announced the initiation of a…
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STRYKER RECEIVES FDA CLEARANCE FOR MAKO TOTAL KNEE APPLICATION
Kalamazoo, Michigan – August 6, 2015 – Stryker Orthopaedics, a division of Stryker Corporation (NYSE:SYK), today announced that its 510(k)…
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FDA CLEARS 3D PRINTED SPINAL IMPLANT
By Biloine Young The Food and Drug Administration has granted 510(k) clearance to Oxford Performance Materials, Inc.’s SpineFab VBR Implant system.…
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Financial
Amedica Announces Preliminary Q2 2015 Financial Results and Update on Recent FDA Response
SALT LAKE CITY, July 27, 2015 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), a biomaterial company that has developed silicon nitride ceramics…
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Hospitals
Stimwave Receives FDA Clearance for World’s First Injectable Wireless MicroSize Pain Relief System for Chronic Back and Leg Pain
Stimwave Technologies Incorporated, a medical device manufacturer and independent research institute headquartered in Miami Beach, Fla., has received FDA clearance…
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Hospitals
Oxford Performance Materials’ SpineFab VBR gets FDA clearance — 5 key notes
Oxford Performance Materials achieved FDA 510(k) clearance for the SpineFab VBR implant system. Here are five things to know: 1.…
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FDA Clears OPM’s 3D Printed Spinal Implants
By Michael Motich-Hou Oxford Performance Materials was the first company to receive FDA approval for a polymer implant for their unique skull…
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FDA Clearance for joimax EndoLIF On-Cage: 3D-Printed Fusion Implant
IRVINE, Calif.–(BUSINESS WIRE)–The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced…
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Captiva Spine’s TowerLOX MIS Pedicle Screw System Receives Clearance for Enhanced Rod Insertion and Reduction
Jupiter, FL, July 08, 2015 –(PR.com)– Captiva Spine, Inc., a medical device organization dedicated to creating and maintaining sincere, honest,…
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Hospitals
Amedica Corporation Provides Update on FDA Questions and Femoral Head Testing Protocol Feedback
SALT LAKE CITY, July 7, 2015 — Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform,…
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Hospitals
New US FDA guidance: Six benefit-risk factors to include in medical device IDE applications
By Stewart Eisenhart In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the…
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