FDA 510(k) Clearance
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Spine
SI-BONE, Inc. Receives 510(k) Clearance and FDA Breakthrough Device Designation for Pelvic Fracture Fixation System
SANTA CLARA, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to…
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Spine
Life Spine Announces FDA 510(k) Clearance for the ARx® SAI Spinal Fixation System
HUNTLEY, Ill., July 31, 2024–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Regulatory
Stryker’s Spine Guidance 5 Software featuring Copilot receives 510(k) clearance from FDA
Q Guidance System with Spine Guidance 5 Software featuring Copilot is a first-to-market technology, pioneering new planning and surgical capabilities LEESBURG,…
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Robotics
THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System (TMINI 1.1)
FREMONT, Calif., July 23, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its…
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Regulatory
Camber Spine Receives FDA Clearance for SPIRA-A Integrated Fixation System
KING OF PRUSSIA, PA., July 23, 2024 – OrthoSpineNews – Camber Spine, a leading innovator in spine and medical technologies,…
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Spine
eCential Robotics Receives FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device
GIÈRES (GRENOBLE), France and NASHVILLE, Tenn., July 22, 2024 /PRNewswire/ — eCential Robotics is proud to announce that it has received 510(k) clearance from the…
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Regulatory
DePuy Synthes Receives 510(k) FDA Clearance of the VELYS™ Robotic-Assisted Solution for Use in Unicompartmental Knee Arthroplasty Procedures
System Will Utilize the SIGMA™ HP Partial Knee Implant, Which Demonstrated Improved 12-Year Survivorship Compared to Class PALM BEACH GARDENS,…
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Regulatory
FX Shoulder Solutions, Inc. Receives FDA 510k Clearance for Full-Wedge Augmented Glenoid Baseplates
ADDISON, Texas , May 16, 2024 /PRNewswire/ — FX received 510k clearance for its full-wedge augmented glenoid baseplates. The newly cleared baseplates bring 6 new…
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Regulatory
Orthofix Announces FDA 510(k) Clearance for the Rodeo Telescopic Nail
LEWISVILLE, Texas, May 9, 2024–(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced that it…
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Regulatory
OrthoXel Receives FDA 510(k) Clearance for their Vertex Hip Fracture Nail (HFN)
OrthoXel is delighted to announce 510(k) clearance for the Vertex Hip Fracture Nail (HFN). CORK, Ireland, May 9, 2024 /PRNewswire/ — The…
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Biologics
Biogennix Receives FDA Clearance for Expanded Use of Agilon Moldable and Morpheus Moldable Products
Agilon Moldable Morpheus Moldable IRVINE, Calif. — May 8, 2024 — Irvine-based Biogennix, LLC an osteobiologics company specializing in bone…
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Spine
Spinal Simplicity announces FDA 510(k) Clearance of its Sacroiliac Joint System, the Patriot-SI Posterior Implant, With a Unique Hybrid Indication for Use
Spinal Simplicity announced the FDA 510(k) clearance of its Patriot-SI Posterior Implant System, designed for sacroiliac joint fusion in combination…
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Top Stories
3D Systems Announces FDA Clearance for World’s First 3D-Printed PEEK Cranial Implants
FDA clearance enables wide-spread adoption of 3D Systems self-contained, cleanroom environment-based printing system, the EXT 220 MED, with medical-grade PEEK…
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Robotics
Synaptive Medical Receives FDA 510(k) Clearance for Near-Infrared Fluorescence Visualization, Expanding Application of Existing Robotic Exoscope
Near-Infrared fluorescence now available on Modus X robotic exoscope, complementing system’s existing advanced fluorescence capabilities New Infrared fluorescence enables the…
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