FDA (510)k Clearance
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Hospitals
Astura Medical Receives FDA 510(k) Clearance For BRIDALVEIL OCT Stabilization System
CARLSBAD, CA – October 19, 2017 – Astura Medical, a high growth, innovative spine technology company, today announced that it…
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Hospitals
Game Ready® Receives FDA 510(k) Clearance For Med4 Elite™ Multi-Modality Recovery Device
CONCORD, Calif., Oct. 6, 2017 /PRNewswire/ — The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received…
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Hospitals
K2M Receives FDA Clearance for Next-Generation YUKON™ OCT Spinal System
LEESBURG, Va., Sept. 29, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex…
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Hospitals
EOI Announces FDA Clearance for the FLXfit15, the Only 3D Articulated Expandable Cage With 15 degrees of Lordosis Correction
OR AKIVA, Israel, September 28, 2017 /PRNewswire/ — Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative…
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Hospitals
Providence Medical Technology Expands Offering of Posterior Cervical Fusion Solutions
WALNUT CREEK, Calif., Sept. 27, 2017 /PRNewswire/ — Providence Medical Technology, an innovator in cervical spine fusion, today announced FDA 510K clearance for…
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Hospitals
Spinal Resources, Inc.®’s Swedge Pedicle Screw System Receives FDA 510(k) Clearance
FT. LAUDERDALE, Fla., Sept. 7, 2017 /PRNewswire/ — Spinal Resources, Inc.® (SRI) announced that it has received FDA 510(k) clearance for its Swedge™ Pedicle Screw…
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Hospitals
OMNIlife science™, Inc. Receives 510(k) Clearance from FDA for Revolutionary Robotic Tissue Balancing Device
AYNHAM, Mass., Sept. 6, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and…
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Hospitals
NuVasive Receives FDA 510(k) Clearance For Leading EOS Innovation
SAN DIEGO, Sept. 6 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with…
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Hospitals
GLOBUS MEDICAL ANNOUNCES FDA 510(K) CLEARANCE FOR EXCELSIUS GPS™
AUDUBON, Pa., Aug. 17, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that…
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Hospitals
ConforMIS Announces FDA 510(k) Clearance for iTotal Hip System
BILLERICA, Mass., June 20, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers knee replacement implants…
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Hospitals
XpandOrtho, Inc. Receives FDA 510(k) Clearance for Its Electronic Soft Tissue Balancing Instrument for Total Knee Replacement Surgery
May 17, 2017 LA JOLLA, Calif.–(BUSINESS WIRE)–XpandOrtho, Inc., a designer of soft tissue balancing instruments, received FDA clearance on April…
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Hospitals
Life Spine Announces 510(k) Clearance of the CRANIAL FUSION System with SOLSTICE® Screws for Cervical Spine Indications
May 09, 2017 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Extremities
CurveBeam Announces FDA 510(k) Clearance for InReach Cone Beam CT Imaging System for the Upper Extremities
WARRINGTON, Pa., May 8, 2017 /PRNewswire/ — CurveBeam announced it has received FDA 510(k) clearance for the InReach, a Cone Beam…
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Hospitals
Additive Orthopaedics Announces FDA Clearance of their Locking Lattice Plating System for the Global Extremities Market
LITTLE SILVER, N.J., April 13, 2017 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that…
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Hospitals
Rivanna Medical has Received FDA Clearance for Accuro™
CHARLOTTESVILLE, Va., Jun 01, 2015 (BUSINESS WIRE) — Rivanna Medical announced today that it has received FDA 510(k) clearance to market Accuro™,…
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