FDA 510(k) Clearance
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Extremities
IlluminOss Medical Receives FDA Clearance for Use in Femur and Tibia Fractures as a Supplement to Approved Hardware
EAST PROVIDENCE, R.I., Oct. 29, 2020 /PRNewswire/ — IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced an…
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Extremities
Anika Announces FDA 510(k) Clearance for its WristMotion® Total Arthroplasty System for the Replacement of Painful Wrist Joints
BEDFORD, Mass., Oct. 21, 2020 (GLOBE NEWSWIRE) — Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company that creates and delivers…
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Extremities
Tyber Medical Receives FDA Clearance on Foot and Ankle Plating Systems
BETHLEHEM, Pa., Oct. 21, 2020 /PRNewswire/ — Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the…
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Extremities
Acuitive Technologies Granted FDA 510(k) Clearance for CITREGEN™ CITRELOCK™ Tendon Interference Screw System
ALLENDALE, N.J., Oct. 21, 2020 /PRNewswire/ — Acuitive Technologies today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITRELOCK™ Interference Screw System…
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Regulatory
Implanet and SeaSpine Announce FDA Clearance of the Mariner Cap System
October 19, 2020 BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans)…
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Extremities
OSSIO Awarded FDA 510(k) Clearance for OSSIOfiber® Compression Screw Portfolio
Company Successfully Surpasses 1,000th Implantation Milestone for its Strong and Bio-integrative OSSIOfiber® Technology WOBURN, Mass., October 19, 2020– OSSIO, Inc.,…
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Regulatory
Orthofix FIREBIRD SI Fusion System Receives Additional FDA Clearance for Nanotechnology
October 1, 2020 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device and biologics company with a spine and…
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Biologics
SurGenTec® Announces First-of-its-Kind FDA Clearance for its 3D GraftRasp System™ Including Key Spine Indications
October 1, 2020 BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec, a privately held spine and orthopedic technology company dedicated to creating safe and…
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Recon
Conformis Announces 510(k) Clearance for Cordera™ Hip System
BILLERICA, Mass., Sept. 29, 2020 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ: CFMS) today announced 510(k) clearance by the U.S. Food and Drug…
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Extremities
Carbon22 Receives FDA 510(k) Clearance for FusionFrame™ Ring Lock System
ENGLEWOOD CLIFFS, NJ, USA, September 29, 2020 /EINPresswire.com/ — Carbon22, a GLW, Inc. company, (“Carbon22”) announced today that it has…
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Extremities
The 510(k) clearance of accessories for the SixFix® Circular Fixation System improves versatility and ease-of-use
COLLIERVILLE, Tenn., Sept. 25, 2020 /PRNewswire/ — AMDT Holdings, Inc. develops disruptive products to address existing and emerging needs in the extremity market.…
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Regulatory
Life Spine Announces FDA 510(k) Clearance for SI Joint Revision Offering and Additional Claims for the SImpact® Sacroiliac Joint Fixation System
September 22, 2020 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Regulatory
FDA grants CTL Amedica 510k clearance for MONDRIAN LIF Cage System
DALLAS (PRWEB) SEPTEMBER 02, 2020 CTL Amedica Corporation is proud to announce that it has received official 510k clearance from the…
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Extremities
ExsoMed Corporation Announces FDA 510(k) Clearance of InFrame™ Intramedullary Micro Nail for Proximal Phalanx Fractures
ALISO VIEJO, CALIF. (PRWEB) SEPTEMBER 01, 2020 ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative…
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Biologics
SurGenTec® Announces FDA Clearance for OsteoFlo® NanoPutty® (Quadphasic Synthetic Bone Graft)
August 26, 2020 BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec, a privately held spine and orthopedic technology company, announced today that it has…
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