FDA 510(k) Clearance
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Regulatory
Spineway-VEOS FDA 510(k) clearance
Spineway obtains 510(k) clearance from the FDAfor its VEOS spinal fixation system Ecully, October 19, 2023- Spineway Group, a specialist…
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Spine
MiRus Announces FDA 510(k) Clearance for Molybdenum-Rhenium (MoRe®) Low Profile Anterior Cervical and Lateral Lumbar Plating Systems
ATLANTA, Oct. 18, 2023 /PRNewswire/ — MiRus® announced that it has received FDA 510(k) clearance of the CYGNUS™ MoRe® Anterior Cervical Plate…
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Spine
Orthofix Announces 510k Clearance and Full Commercial Launch of OsteoCove, an Advanced Bioactive Synthetic Graft for use in Spine and Orthopedic Procedures
LEWISVILLE, TX, October 12, 2023 /OrthoSpineNews/ Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the 510k…
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Spine
Xēnix Medical neoWave™ Interbody Systems Receive FDA Clearance for NANOACTIV™ Nanotechnology Surface
Nanotechnology 510(k) Clearance a Significant Milestone for Implant Family with Over 7,000 Devices Implanted ORLANDO, Fla., October 10, 2023–(BUSINESS WIRE)–Xēnix…
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Spine
DePuy Synthes Receives FDA Clearance for the TriALTIS™ Spine System and Navigation Enabled Instruments
Latest advancement in Spine portfolio delivers next generation thoracolumbar implant system designed for seamless integration with enabling technology RAYNHAM, Mass.…
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Extremities
Exactech Expands Vantage® Ankle Portfolio with Clearance of Advanced Activit-E™ Polyethylene
The new technology will be displayed at AOFAS Booth #301 this week. GAINESVILLE, Fla., September 21, 2023 — (BUSINESS WIRE)–…
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Regulatory
Stryker’s Pangea Systems Receive FDA Clearance
Pangea to offer a comprehensive and versatile portfolio, providing variable-angle plating for a variety of patient populations KALAMAZOO, Mich., September…
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Extremities
OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Pediatric Nailing Platform | Tibia
WARSAW, Ind., Sept. 11, 2023 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of…
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Regulatory
OnPoint Surgical Receives 510(k) Clearance for the OnPoint Augmented Reality Spine System
BOSTON, Sept. 11, 2023 /PRNewswire/ — OnPoint Surgical, Inc., a member of a group of privately held OnPoint companies pioneering augmented reality…
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Recon
Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene
Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene GAINESVILLE, Fla., August 21, 2023–(BUSINESS WIRE)–Exactech, a developer and…
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Spine
Alevio Spine Announces 510(k) Clearance of Expanded Implant Options for the SI-Cure® SI Joint Fusion System
Birmingham, AL, August 21, 2023 /OrthoSpineNews/ – Alevio® Spine, a leader in the treatment of sacropelvic conditions, today announced 510(k)…
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Regulatory
icotec ag Announces FDA 510(k) Clearance for VADER® Pedicle System Navigated Instruments, Advancing Precision and Safety in Spinal Implantation
ALTSTAETTEN, Switzerland, July 27, 2023 /PRNewswire/ — icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the…
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Spine
NanoHive Medical, LLC Expands Hive™ 3D Printed Titanium Device Portfolio and Indications
Boston, MA, July 18, 2023 – OrthoSpineNews – NanoHive Medical has received 510(k) clearance from the U.S. Food and Drug…
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Regulatory
AlloSource Receives FDA 510(k) Clearance For AceConnex™ Pre-Sutured Fascia For Hip Labral Reconstruction And Augmentation
First pre-sutured fascia allograft designed for hip arthroscopists to help increase surgeon efficiency and reduce operating room time CENTENNIAL, Colo., July…
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Regulatory
PathKeeper Surgical Receives FDA 510k Clearance for Spine Navigation System
PathKeeper improves clinical experience and reduces the reliance on radiation in spine surgery KFAR SABA, ISRAEL (PRWEB) JUNE 15, 2023 –…
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