510k
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Nextremity Solutions, Inc. Receives FDA 510(k) Approval for the Arcus(TM) Staple System
WARSAW, Ind., Sept. 8, 2015 (GLOBE NEWSWIRE) — Nextremity Solutions, Inc., a pure-play foot and ankle company, recently received 510(k)…
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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
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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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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St. Jude receives FDA 510(k) clearance for mobile-enabled spinal cord stimulation trial system
By Aditi Pai St. Jude Medical has announced that it received FDA 510(k) clearance for the St. Jude Medical Invisible Trial System, which is…
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Hospitals
25 spine devices receive FDA 510(k) clearance in June
By Laura Dyrda The Food and Drug Administration cleared 25 spine devices in June. 1. Captiva Spine SmartLOX Cervical Plate System from Captiva…
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Financial
K2M Announces Enhanced Complex Spine Portfolio With Addition of Its Innovative NILE(TM) Alternative Fixation Spinal System
LEESBURG, Va., March 25, 2015 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global medical…
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Hospitals
510k Submission to the FDA (Case Study – Part 1)
Posted by Rob Packard This article is the first part of a two-part case study providing an overview of the pre-market…
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Spine
Medtronic Receives Expanded Indications of the VERTEX® Reconstruction System
Now FDA Cleared for Lateral Mass and Pedicle Screw Fixation in the Posterior Cervical Spine DUBLIN – Feb. 16, 2015…
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Hospitals
Regulatory affairs for medical device startups
February 13, 2015 by Andrew Ahn Instilling a robust quality management system as soon as possible is crucial in becoming a successful…
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Spine
Amedica Submits 510(k) Application to FDA for Composite Spinal Interbody Spacers With Porous Silicon Nitride Center
SALT LAKE CITY, Feb. 12, 2015 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride…
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