clearance
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Spine
4WEB Medical Announces Regulatory Clearance of its Anterior Spine Truss System with Anchor Fixation
Company expands product offering for its anterior lumbar interbody fusion device portfolio DALLAS, April 25, 2024 /PRNewswire/ — 4WEB Medical, an orthopedic implant…
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Extremities
Tyber Medical Anatomical Plating System Cleared For Canada
Comprehensive portfolio of fixation devices for the extremities is now available BETHLEHEM, Pa., Feb. 6, 2024 /PRNewswire/ — Tyber Medical LLC, a…
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Regulatory
FDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis
Implantable shock absorber (ISA) relieves pain and improves function in people ineligible for, or unwilling to undergo, joint replacement MISHA…
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Recon
Conformis, Inc. Announces Clearance in Australia for iTotal® PS, the Only Personalized, Posterior-Stabilized Total Knee Replacement System
The iTotal® PS total knee replacement system is designed so that its patient-specific implants fit the unique size and shape…
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Hospitals
Medtronic Announces New Bone Cement Indication for Treating Sacral Fractures
DUBLIN – March 14, 2017 – Medtronic plc (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA)…
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Hospitals
Centric Medical™ Announces FDA Clearance of Metatarsal Hemi Implant System
February 14, 2017 HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for…
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Hospitals
Spinal Simplicity Announces Receipt of FDA Clearance for Minuteman® G3-R Removable End Fusion Implant
OVERLAND PARK, KANSAS (PRWEB) FEBRUARY 03, 2017 Spinal Simplicity, a medical device company developing innovative solutions to treat complex surgical…
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Hospitals
DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screw Systems
RAYNHAM, Mass., Jan. 26, 2017 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received…
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Hospitals
OrthAlign, Inc. Announces FDA Clearance for Direct Anterior Approach HipAlign
Aliso Viejo, CA – January 25, 2017 – OrthAlign, Inc., a privately held U.S.-based medical device and technology company, received…
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Hospitals
Implanet Announces Global Marketing Clearance of the New JAZZ FRAME®
January 25, 2017 BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a…
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Hospitals
7D Surgical Receives FDA 510(K) and Health Canada MDL Clearance for Its Breakthrough Image Guidance System for Spine Surgery
TORONTO, Jan. 23, 2017 /PRNewswire/ — 7D Surgical announced today that it has received both 510(k) clearance from the U.S. Food and…
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Hospitals
Camber Spine Technologies Announces 510(k) Clearance For Their Siconus(TM) SI Joint Fixation System
WAYNE, Pa., Jan. 23, 2017 — (Healthcare Sales & Marketing Network) — Camber Spine Technologies, today announced that it has…
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Hospitals
Amplitude Surgical Announces That is Has Been Granted Approval to Market Its Anatomic® Total Knee Prosthesis in the United States
January 20, 2017 VALENCE, France–(BUSINESS WIRE)–Regulatory News: Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player…
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Hospitals
Precision Spine® Announces 510(k) Clearance of the ShurFit® ACIF 2C System
January 18, 2017 PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has announced today that…
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Hospitals
CyMedica Orthopedics® announces FDA clearance for e-vive™, the first app-driven muscle activation therapy and patient engagement solution for pre and post-operative knee surgery rehabilitation
SCOTTSDALE, Ariz., Jan. 17, 2017 /PRNewswire/ — CyMedica Orthopedics®, developer and manufacturer of innovative muscle rehabilitation systems announced that it received U.S.…
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