FDA 510(k) Clearance
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Biologics
Ventris Medical Receives 510(k) Additional Clearance for Amplify® Standalone Bone Graft Putty
Amplify® – Activated Bone Graft NEWPORT BEACH, Calif., March 13, 2024 /PRNewswire/ — Ventris Medical, a privately held orthobiologics and tissue regeneration…
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Regulatory
SurGenTec® Receives FDA Clearance for OsteoFlo® HydroPutty™, a Hydrophilic Synthetic Bone Graft
BOCA RATON, Fla., March 7, 2024–(BUSINESS WIRE)–SurGenTec, a pioneering medical device company specializing in orthopedic and spine technologies, proudly announces…
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Regulatory
Zimmer Biomet Receives FDA Clearance for ROSA® Shoulder System – the World’s First Robotic Assistant for Shoulder Replacement Surgery
The ROSA® Shoulder System Becomes the First-to-Market Robotic Surgical Assistant for Shoulder Arthroplasty and the Fourth ROSA Robotics Application in Five…
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Spine
MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System
WASHINGTON, Feb. 20, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and…
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Regulatory
Bone Solutions Receives 510(k) Clearance for Expanded Indications of Use for Mg OSTEOCRETE in Intervertebral Body Fusion Procedures
Colleyville, TX., February 13, 2024 — OrthoSpineNews — Bone Solutions Inc., an orthobiologics technology company located in Colleyville, Texas, announced…
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Extremities
Tyber Medical Acquires FDA Clearance for Proximal Tibia Plating System
Featuring Single/Multiple Component Metallic Bone Fixation BETHLEHEM, Pa., Feb. 12, 2024 /PRNewswire/ — Tyber Medical LLC, a leading orthopedic device manufacturer providing…
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Top Stories
IlluminOss Receives 510K Clearance for a New Light Console for its Implants that Provide Strength for Fragile and Geriatric Bone
New Console Reduces Curing Time by up to 50% EAST PROVIDENCE, R.I., Jan. 31, 2024 /PRNewswire/ — By combining years of clinical…
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Regulatory
SI-BONE, Inc. Receives FDA 510(k) Clearance for a Smaller Diameter iFuse Bedrock Granite Implant with an Expanded Indication and Application
SANTA CLARA, Calif., Jan. 30, 2024 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated…
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Extremities
Tyber Medical Receives FDA Clearance on Plating System Line Extension
Tyber Medical Broadens Its Vast Plating Portfolio with FDA Approval of Additional Screw and Plate Options, and Indications for Mini-Frag…
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Extremities
Tyber Medical Granted FDA Clearance on Distal Radius Plating System
Tyber Medical Expands Its Extensive Plating Portfolio with FDA Approval of Distal Radius Plating System for Fractured Radius, Ulna and…
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Regulatory
Spinal Simplicity Announces 510(K) FDA Clearance of Its Novel Sacroiliac Joint System, the Liberty-SI Lateral Implant
Spinal Simplicity’s Liberty-SI Lateral Implant System is a revolutionary sacroiliac joint fusion technology designed for safer and potentially less invasive…
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Regulatory
Exactech Announces FDA 510(k) Clearance of the World’s First Surgical Navigation for Total Ankle Replacement
GAINESVILLE, Fla., December 5, 2023–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation and smart technologies for joint replacement…
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Regulatory
POLARIS AR Receives Clearance From The U.S. Food And Drug Administration For STELLAR Knee
MIAMI, Nov. 3, 2023 /PRNewswire/ — POLARISAR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S.…
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Spine
FloSpine Revolutionizes Treatment for Spinal Stenosis with FDA Clearance of KeyLift™ System
KeyLift is the fifth FDA-approved product developed by FloSpine, all invented at the Research Park at Florida Atlantic University® BOCA…
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Recon
THINK Surgical’s TMINI System Receives FDA Special 510(k) Clearance for Use With Additional Implants
FREMONT, Calif., Oct. 23, 2023 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that…
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