FDA 510(k) Clearance
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Regulatory
SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene® Surface Technology
CARLSBAD, Calif., Dec. 15, 2020 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on…
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Regulatory
icotec ag Receives FDA Clearance for the VADER® Pedicle – System with Bone Cement Augmentation
ALTSTAETTEN, Switzerland, Nov. 10, 2020 /PRNewswire/ — icotec ag, the leading medical device manufacture of Carbon/PEEK spinal implants, announces the U.S. Food and Drug…
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Regulatory
Astura Medical Receives FDA 510(k) Clearance For Dolomite Stand-Alone Anterior Cervical Stabilization System
IRVING, TX – November 9, 2020 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has…
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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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