clearance
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Hospitals
Avitus Orthopaedics Receives 510(k) Clearance and Launches the Avitus™ Bone Harvester
FARMINGTON, CT (PRWEB) JUNE 08, 2016 Avitus Orthopaedics Inc.(Avitus), a developer of medical devices that improve outcomes while decreasing healthcare…
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Hospitals
MẌ Orthopedics Receives FDA Clearance on the dynaMẌ™ Nitinol Compression Screw
LEXINGTON, Mass., June 7, 2016 /PRNewswire/ — MẌ Orthopedics, Corp. (MẌO), an orthopedic implant company focused on improving implant/bone fixation, is proud…
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Hospitals
Additive Orthopaedics Announces the 510(k) Clearance of Their 3D Printed Digital Fusion Implant for the Global Extremities Market
LITTLE SILVER, N.J., June 1, 2016 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received…
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Hospitals
K2M Enhances 3D-Printed Spine Portfolio Following FDA Clearance of Two CASCADIA™ Interbody Systems Featuring Lamellar 3D Titanium Technology™
LEESBURG, Va., June 01, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (KTWO) (the “Company” or “K2M”), a global medical…
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Hospitals
Interventional Spine, Inc. announces FDA Clearance of Lordotic Opticage™
IRVINE, Calif., May 24, 2016 /PRNewswire/ — Interventional Spine, Inc. announced today FDA clearance of its 80 Lumbar Lordotic Opticage™ Expandable Intervertebral Body Fusion…
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Spine
Implanet granted regulatory clearance in the USA (510k) and Europe (CE) for the Jazz Claw
Bordeaux, Boston, May 23, 2016 – IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in…
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Hospitals
Bone Index Receives FDA 510(k) Clearance for the Bindex® Point-of-care Instrument to Help Physicians in Diagnosing Osteoporosis
KUOPIO, Finland, May 16, 2016 /PRNewswire/ — Bone Index Ltd., one of Europe’s top new manufacturers of medical devices, has…
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Extremities
First Ray Receives FDA 510(k) Clearance for CortiClamp™ Small Bone Fixation System
LOGAN, Utah, May 16, 2016 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for…
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Spine
Xtant™ Medical Announces the FDA Clearance for the Posterior Cervical Screw Indication on Certex® Spinal Fixation System
BELGRADE, Mont., May 12, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of…
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Spine
Camber Spine Technologies Receives FDA Clearance for ENZA™ Zero
WAYNE, Pa., May 5, 2016 – Camber Spine Technologies announces that it has received 510(k) clearance from the U.S. Food…
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Hospitals
Revival™ Modular Revision Stem gains 510(k) clearance
3 May 2016 Corin is pleased to announce 510(k) clearance in the US for a range of modular titanium…
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Extremities
First Ray Receives FDA 510(k) Clearance for Stealth Staple™
LOGAN, Utah, May 3, 2016 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving…
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Spine
Intelligent Implant Systems Receives 510(k) Clearance for Two-Level Revolution™
Intelligent Implant Systems announced today that the two-level components for the Revolution™ Spinal System were cleared by the FDA via…
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Extremities
Exactech Receives FDA 510(k) Clearance for Vantage™ Total Ankle
GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech Inc. (Nasdaq:EXAC), a developer and producer of bone and joint restoration products for extremities, knee, hip, spine…
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Spine
K2M’s MESA® Mini and DENALI® Mini Spinal Systems Receive Additional FDA Clearance for Posterior Cervical Spine Fixation
LEESBURG, Va., April 06, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on…
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