FDA 510(k) Clearance
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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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Recon
Conformis Actera™ Hip System Receives 510(k) Clearance from the U.S. Food and Drug Administration
New design adds increasingly more common tri-taper femoral stem design and direct anterior approaches to the expanding Conformis family of…
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Biologics
Ventris Medical Receives 510(k) Clearance for Amplify® Standalone Bone Graft Putty and Bone Graft Extender
NEWPORT BEACH, Calif., Sept. 14, 2022 /PRNewswire/ — Ventris Medical, a privately held orthobiologics and tissue regeneration company, today announced that the…
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Robotics
eCential Robotics receives FDA clearance for its surgical robotic platform for spine surgery
GIÈRES, France, Sept. 1, 2022 /PRNewswire/ — eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging,…
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Spine
NeuraMedica Inc. Receives FDA 510(k) Clearance for DuraFuse Dural Clips for Fast & Secure Dural Closure
Oregon City, Oregon, August 31, 2022 /OrthoSpineNews/ – NeuraMedica Inc., a medical device company developing innovative products for neurosurgery, has…
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Regulatory
Innovasis Announces FDA Clearance of the First HA Porous PEEK Interbody Fusion Device
Salt Lake City, Aug. 30, 2022 /OrthoSpineNews/ – Innovasis®, the leader in Bioactive spine applications, today announced it has received U.S. Food…
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Regulatory
Surgalign Announces FDA 510(k) Clearance of the Cortera™ Spinal Fixation System – The Company’s New Flagship Posterior Fixation Platform
DEERFIELD, Ill., Aug. 24, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc., (NASDAQ: SRGA) a global medical technology company focused on…
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Regulatory
Point Robotics Receives FDA 510(k) Clearance for its Point™ Kinguide Robotic-Assisted Surgical System to Push the Boundaries of Precision Spinal Surgeries
August 23, 2022 – Point Robotics MedTech Inc., /OrthoSpineNews/ – (Point Robotics), a rising leader in the field of minimal…
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Biologics
Zavation Medical Products, LLC, receives FDA 510K Clearance for Varisync™ Anterior Cervical Plate and Spacer system as an addition to its cervical spine portfolio
FLOWOOD, Miss., Aug. 18, 2022 /PRNewswire/ — Zavation Medical Products (“Zavation” or the “Company”), an innovative designer and manufacturer of high-quality spinal implants,…
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Spine
VySpine Announces FDA Clearance for VyPlate Anterior Cervical Plate System
Tallahassee, FL – August 16, 2022 / OrthoSpineNews /—VySpine, a spine innovation leader using differentiated materials and designs, announced today…
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Recon
MicroPort Navibot Receives 510(K) Clearance for its SkyWalker™ Robot-Assisted Platform for Orthopedic Applications
ARLINGTON, Tenn., Aug. 8, 2022 /PRNewswire/ — MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United…
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Regulatory
Medtronic receives FDA clearance for next-generation UNiD™ Spine Analyzer with degenerative spine surgery predictive model
Powered by a database of over 10,000 surgical cases, Medtronic continues to evolve the UNiD™ platform to help surgeons plan…
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Spine
Cutting Edge Spine Announces FDA 510(k) Clearance of T-FIX 3DSI Joint Fusion System with Proprietary Trabecular Technology
The T-FIX 3DSI Joint Fusion System is the first of many systems from Cutting Edge Spine to implement proprietary trabecular…
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Biologics
Mg OSTEOINJECT from Bone Solutions Receives 510(k) Clearance for Expanded Indications
Colleyville, TX, July 13, 2022 /OrthoSpineNews/— Bone Solutions Inc. (BSI), an orthobiologics technology company located in Colleyville, Texas, announced today that it has…
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Spine
Altus Spine Announces FDA Clearance of Sochi OCT System
West Chester, PA – Tuesday, June 21st, 2022 /OrthoSpineNews/ – Altus Spine, a leader in the development and innovation of medical…
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