FDA 510(k) Clearance
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Spine
Spinal Alignment Solutions Announces FDA 510(k) Clearance for the Pelvic Incidence (PI) Rod System
December 5, 2024 – OrthoSpineNews – Spinal Alignment Solutions (S.A.S) is proud to announce that the U.S. Food and Drug…
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Recon
THINK Surgical Receives FDA 510(k) Clearance for MOBIO™ Knee System implants on TMINI® Miniature Robotic System
FREMONT, Calif., Nov. 20, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that…
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Recon
THINK Surgical Receives FDA 510(k) Clearance to use Freedom® Total Knee, Freedom Titan® Knee, and Freedom Primary PCK® System implants with TMINI® Miniature Robotic System
FREMONT, Calif., Nov. 19, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature…
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Regulatory
THINK Surgical Receives FDA 510(k) Clearance for Use of LinkSymphoKnee (LSK) implants With TMINI Miniature Robotic System
FREMONT, Calif., Nov. 18, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that…
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Biologics
Acuitive Technologies Receives FDA 510(k) Clearance for CITREPORE™, A New Synthetic Bioactive Bone Void Filler for Orthopedic Procedures
ALLENDALE, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) — Acuitive Technologies, Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CITREPORE, a…
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Top Stories
Foundation Surgical Unveils Revolutionary Motion Preservation Procedure with 510(k) Clearance
Scottsdale, AZ – November 11, 2024 — OrthoSpineNews — Foundation Surgical, an innovative leader in spinal implant technology, is thrilled…
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Recon
Corin Announces FDA 510(k) Clearance for New Icona™ Femoral Stem
RAYNHAM, MASSACHUSETTS, UNITED STATES of AMERICA — 5 November 2024 — Corin, a global leader in orthopaedic innovation, today announced 510(k) clearance…
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Recon
Exactech Announces FDA Clearance of Truliant® Porous 3D Tibial Implant for Knee Replacement Surgery
GAINESVILLE, Fla., Oct. 31, 2024 /PRNewswire/ — Exactech, a global medical technology leader, announced today it has received 510(k) clearance from the U.S.…
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Regulatory
Catalyst OrthoScience Announces FDA 510(k) Clearance for Shoulder Fracture System and First Cases
Latest innovation in robust portfolio tackles challenges in shoulder arthritis and complex fractures with a focus on tuberosity fixation and…
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Regulatory
Regenity Biosciences Receives 510(k) Clearance for RejuvaKnee™, a Groundbreaking Regenerative Meniscus Implant Device to Redefine the Standard of Care
Introduction of RejuvaKnee™ expands Regenity’s innovation portfolio of sports medicine solutions, with anticipated market value of more than $900 million PARAMUS,…
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Recon
OrthAlign Receives FDA 510(k) Clearance for Lantern® Hip
IRVINE, Calif., Oct. 3, 2024 /PRNewswire/ — OrthAlign, Inc., a privately held medical device company, announces FDA 510(k) clearance of their Lantern…
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Robotics
THINK Surgical Receives FDA 510(k) Clearance for Zimmer Biomet Persona Knee on TMINI® Miniature Robotic System
FREMONT, Calif., Sept. 5, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its…
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Recon
Maxx Orthopedics announces FDA 510(k) clearance of new Freedom® Titan PCK Revision Knee System and partnership with UNIK Orthopedics, Inc.
FDA 510(k) clearance of new Freedom Titan PCK Revision Knee addresses metal sensitivity in total knee replacement surgery. Strategic partnership…
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Recon
THINK Surgical Receives FDA 510(k) Clearance for Medacta GMK Sphere® and SpheriKA® implants on TMINI® Miniature Robotic System
FREMONT, Calif., Aug. 29, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that…
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Regulatory
SurGenTec Receives FDA Clearance for B-MAN Bone Marrow Aspirate Kit with Integrated Filtration
BOCA RATON, Fla., August 27, 2024–(BUSINESS WIRE)–SurGenTec, an innovative medical device company specializing in orthopedic and spine technology, is thrilled…
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