FDA 510(k) Clearance
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Recon
Fuse Medical, Inc. Announces FDA 510(k) Clearance of the Sterizo™ Tibial Revision Knee System and PS Plus Posterior Stabilized Tibial Insert
August 26, 2021 RICHARDSON, Texas–(BUSINESS WIRE)–Fuse Medical, Inc. (OTCPINK: FZMD) (“Fuse” or the “Company”), an emerging manufacturer and distributor of…
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Recon
Shoulder Innovations Announces FDA 510(k) Clearance For InSet™ Reverse Shoulder Platform Technology
HOLLAND, Mich., Aug. 23, 2021 /OrthoSpineNews/ — Shoulder Innovations Inc, a leading innovator in the development of shoulder replacement systems, announced today that they…
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Recon
Zimmer Biomet Receives FDA Clearance for ROSA® Hip System for Robotically-Assisted Direct Anterior Total Hip Arthroplasty
ROSA® Hip and ONE Planner™ Hip Further Strengthens Zimmer Biomet’s Comprehensive ROSA® Robotics Portfolio; Enhances ZBEdge and Complements Already Available…
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Regulatory
Globus Medical Announces FDA 510(k) Clearance for Excelsius3D™
Excelsius3D™ – Intelligent 3-in-1 Intraoperative Imaging System AUDUBON, Pa., Aug. 16, 2021 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE: GMED), a…
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Regulatory
Able Medical Announces FDA 510K Clearance for the MACH™ Screw Clip System
The MACH system, a pre-loaded screw system, clips onto the Valkyrie™ Thoracic Fixation System August 11, 2021 MARQUETTE, Mich.–(BUSINESS WIRE)–Able…
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Regulatory
Aurora Spine Corporation Announces FDA 510(k) Clearance for DEXA-C™ Cervical Interbody System
Product approval is the first in the world using Company’s proprietary and patented DEXA Technology™ for custom made implants based…
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Regulatory
Camber Spine Receives FDA Clearance for SPIRA-P and SPIRA-T Technologies
KING OF PRUSSIA, PA — August 3, 2021 – Camber Spine, a leading innovator in spine and medical technologies, announced…
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Regulatory
NuVasive Receives Latest FDA 510(k) Clearance for Pulse Platform and Announces Commercial Launch
First-of-its-kind platform integrates multiple technologies to address most common clinical challenges in spine surgery SAN DIEGO, July 30, 2021 /PRNewswire/ — NuVasive, Inc.…
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Regulatory
Via Surgical Receives FDA Clearance for Industry’s First Orthopedic Suture-Based Fixation System
The TissueTak™* tendon anchor is the first closed-loop suture based fixation for soft tissue to soft tissue repair of certain…
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Regulatory
SeaSpine Announces FDA 510(k) Clearance of 7D Surgical Percutaneous Spine Module for Minimally Invasive Surgery
July 7, 2021 / Source: SeaSpine Holdings Corporation CARLSBAD, Calif., July 07, 2021 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE),…
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Extremities
Onkos Surgical Announces FDA 510(k) Clearance of its BioGrip® Modular Porous Collars, a First-of-Its-Kind Solution to Help Address Implant Loosening in Orthopaedic Oncology and Complex Revision Surgery
The new offering, available as part of the ELEOS™ Limb Salvage System, is designed to help support bone ingrowth in…
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Regulatory
CoreLink Announces FDA Clearance of F3D Corpectomy System
CoreLink expands 3D printed spine implant portfolio with the F3D Corpectomy Vertebral Body Replacement System (VBR), featuring a wide range…
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Regulatory
Life Spine Announces FDA 510(k) Clearance for the PROLIFT® Lateral HELO Fixation System
May 4, 2021 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a leading medical device company that designs, develops, manufactures and markets products for…
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Recon
Pixee Medical Receives FDA Clearance for Knee+
Digitally augmented surgeons are to become a reality in the USAFocus on total knee arthroplasty in ambulatory surgery centers April…
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Regulatory
Spinal Elements® Announces FDA 510(k) Clearance of Lucent® 3D Additive Manufactured Interbody Devices
The Lucent 3D family of devices is designed to maximize bone graft volume and contain delivery of graft material Carlsbad,…
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