clearance
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Hospitals
SpineGuard® Receives FDA Clearance to Market Its DSG™ Integration Module for Making Pedicle Screws “Smart”
January 16, 2017 PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical…
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Hospitals
Precision Spine® Announces 510(k) Clearance of the AccuFit® Lateral Plating System
December 27, 2016 PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc. announced today that it recently received 510(k) clearance of its AccuFit®Lateral Plating…
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Hospitals
KYOCERA Medical Corporation Receives FDA 510(k) Clearance for Initia® Total Hip System, Featuring BIOCERAM AZUL® Ceramic Femoral Head
December 05, 2016 SAN DIEGO–(BUSINESS WIRE)–Kyocera Medical Corporation, a leading manufacturer of implantable systems and advanced ceramic components, today announced…
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Hospitals
FIREFLY Spinal Navigation Guides receive universal clearance from FDA
December 3, 2016 – George Frey Mighty Oak Medical is a medical device incubator that continues to focus on novel surgical…
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Hospitals
Xtant Medical Receives FDA Clearance for the Xsert™ Lumbar Expandable Interbody System
BELGRADE, Mont., Nov. 23, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of…
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Biologics
Artoss Announces FDA Clearance to Market of NanoBone® SBX Putty
November 8, 2016 Artoss, Inc. is pleased to announce that, on October 26, 2016, Artoss GmbH received notice from the…
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Hospitals
Xtant Medical Receives FDA Clearance to Use Allografts in the Stand-Alone Irix-C™ Cervical Cage
BELGRADE, Mont., Nov. 15, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of…
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Hospitals
FDA Clearance for joimax® Vaporflex® and Legato® Electrosurgical Probes
November 08, 2016 IRVINE, Calif. & KARLSRUHE, Germany–(BUSINESS WIRE)–joimax®, the global acting German developer and marketer of technologies and training…
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Hospitals
SeaSpine Announces 510(k) Clearance from the FDA of Mariner Posterior Fixation System
CARLSBAD, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation(NASDAQ:SPNE), a global medical technology company focused on surgical solutions…
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Hospitals
KATOR Receives FDA Clearance for Knotless Suture Anchor System
LOGAN, Utah, Nov. 8, 2016 /PRNewswire/ — KATOR, a start-up medical device company focused on advanced tissue-to-bone reattachment systems, announces that it…
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Hospitals
MIGHTY OAK MEDICAL RECEIVES SECOND FDA CLEARANCE FOR PATIENT-SPECIFIC 3D PRINTED FIREFLY® PEDICLE SCREW NAVIGATION GUIDES
Englewood, CO — November 7, 2016 — Mighty Oak Medical (http://www.mightyoakmedical.com) announced today that its patient-specific, 3D printed FIREFLY® Pedicle…
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Hospitals
EOS imaging Receives FDA 510(k) Clearance for kneeEOS 3D Surgical Planning Software for Total Knee Arthroplasty
November 07, 2016 PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today that…
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Hospitals
NuVasive Secures Magnetic Resonance (MR) FDA Conditional Clearance for MAGEC System
SAN DIEGO, CA — (Marketwired) — 10/27/16 — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming…
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Hospitals
SeaSpine Announces 510(k) Clearance from the FDA of Shoreline ACS System
CARLSBAD, Calif, Oct. 27, 2016 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment…
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Hospitals
RTI Surgical® Announces Additional 510(k) Clearance for the Streamline® OCT System
ALACHUA, Fla. (October 26, 2016) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, is pleased to announce…
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