FDA 510(k) Clearance
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Spine
Life Spine Announces FDA 510(K) Clearance for the TruLift® Lateral Expandable Spacer System and Lateral Plate System
HUNTLEY, Ill., December 14, 2022 –(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for…
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Spine
Eminent Spine’s ALIF Stand-Alone System Receives FDA 510(K) Clearance in October 2022
Eminent Spine’s ALIF Stand-Alone System includes PEEK and 3D Printed Titanium footprints. The implants are offered as non-sterile. Plano, TX,…
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Recon
Zimmer Biomet Expands Persona® Knee System Portfolio with FDA Clearance of Persona® OsseoTi® Keel Tibia for Cementless Knee Replacement
New Porous Iteration of Anatomic Keeled Tibia Designed to Deliver Stable Initial and Biological Fixation Together with the Clinically Proven Benefits of…
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Extremities
FDA Clearance Awarded to Tyber Medical for NiTy+ One-Shot Staple Fixation System
Innovative Bone Fixation System Offers Surgeons a Single-Step Staple Implantation Process BETHLEHEM, Pa., Nov. 15, 2022 /PRNewswire/ — Tyber Medical LLC, the…
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Recon
Exactech Announces FDA 510(k) Clearance of the TriVerse™ Primary Knee Replacement System
November 4, 2022 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement…
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Robotics
Accelus Announces FDA 510(k) Clearance for Remi Robotic Navigation System Software Update that Allows Image Acquisition with all Major 3D Imaging Systems
PALM BEACH GARDENS, Fla., Nov. 03, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating…
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Regulatory
CurvaFix Receives FDA Clearance for Smaller-diameter, Intramedullary Implant for Pelvic Fracture Fixation
November 1, 2022 BELLEVUE, Wash.–(BUSINESS WIRE)–CurvaFix, Inc., a developer of medical devices to repair fractures in curved bones, today announced…
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Spine
DePuy Synthes Receives FDA Clearance for TELIGEN™ System
New MedTech Advancement Brings First-of-Its-Kind Technology to Spine Surgeons, Delivering Advanced Visualization and User-Centric Procedural Control RAYNHAM, Mass., Oct. 20, 2022 /PRNewswire/…
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Regulatory
OC Spine a division of OC Medical Devices receives approval for Focus Ti family of TLIF interbody devices featuring xCELLerate bioactive surface technology
Savannah GA, October 18, 2022 /OrthoSpineNews/ – OC Spine a division of OC Medical Devices a privately held medical device…
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Spine
ulrich Medical USA™ Receives 510(k) Clearance for Flux-C™ 3D Printed Porous Titanium Cervical Interbody Prior to NASS
ST. LOUIS, Oct. 14, 2022 /PRNewswire/ — ulrich medical USA, Inc., a privately held medical device company focused on developing and commercializing musculoskeletal…
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Spine
Regulatory Clearance for the Align Interbody System with HAnano Surface
Acuity Surgical Devices, LLC has received regulatory clearance from the FDA through a special 510(k) application for their additively manufactured…
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Spine
CTL Amedica gains FDA clearance for MONDRIAN™ ALIF Cage System with Supplementary Fixation Plate
DALLAS, October 11, 2022 /OrthoSpineNews/ – CTL Amedica Corporation has received official 510k clearance from the U.S. Food and Drug…
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Spine
Aurora Spine Corporation Announces FDA 510(k) Clearance for its SiLO TFX™ MIS Sacroiliac Joint Fixation System
CARLSBAD, Calif., Oct. 06, 2022 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF),…
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Spine
Life Spine Announces FDA 510(k) Clearance for the GHOST® 3D-Printed Titanium Spacer System
October 5, 2022 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a leading medical device company that designs, develops, manufactures and markets products for…
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Regulatory
Zimmer Biomet Receives FDA Clearance for Identity™ Shoulder System for Shoulder Replacement
WARSAW, Ind., Sept. 20, 2022 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced…
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