FDA 510(k) Clearance
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Regulatory
FDA Grants CTL Amedica 510k Clearance for the NITRO Interbody Fusion Cage System Family
DALLAS, May 18, 2023 / OrthoSpineNews/ – CTL Amedica Corporation has received 510k clearance from the U.S. Food and Drug…
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Regulatory
Waypoint Orthopedics Announces FDA Clearance of the Waypoint GPS
MALVERN, Pa., May 16, 2023 (Newswire.com) – Waypoint Orthopedics, Inc., a spinal medical device company, announces that the company’s Waypoint GPS™…
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Spine
HAPPE Spine Announces FDA Clearance for the INTEGRATE-C™ Interbody Fusion System
GRAND RAPIDS, Mich., May 8, 2023 /PRNewswire/ — HAPPE Spine, a medical device company focused on bringing innovative materials to orthopaedic implants, announces that…
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Spine
IMPLANET Receives FDA Clearance for Its Squale™ Anterior Cervical Cage Range
April 11, 2023 BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans)…
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Regulatory
restor3d Receives FDA Clearance of Patient Specific Resection Guides for use with the Kinos Axiom Total Ankle System
April 6, 2023 DURHAM, N.C.–(BUSINESS WIRE)–restor3d, a research-driven medical device company, announced that the U.S. Food and Drug Administration (FDA)…
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Extremities
Anika Continues to Expand Addressable Market for Tactoset® Injectable Bone Substitute with Additional 510(k) Clearance from FDA
Tactoset cleared by the FDA to be combined with autologous bone marrow aspirate, a core element for regenerative healing Anika…
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Spine
CoreLink Announces FDA Clearance of Siber® Ti–3D Printed SI Joint Fusion System
ST. LOUIS, March 29, 2023 /PRNewswire/ — CoreLink, LLC , a leading designer and manufacturer of innovative spinal implant systems announced today the 510(k)…
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Regulatory
NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients
SAN DIEGO, March 20, 2023 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with…
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Robotics
Accelus Announces FDA 510(k) Clearance of Remi Robotic Navigation System for Use with 2D Fluoroscopy-Based Imaging System
Remi now cleared for use with most commonly used 2D and 3D imaging systems for spine surgery. PALM BEACH GARDENS,…
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Extremities
FDA Grants Tyber Medical Clearance to Expand Anatomical Plate Portfolio and Additional MR Conditional Designation
One hundred new plates for foot, ankle, hand and wrist indications included in the company’s latest 510(k) clearance BETHLEHEM, Pa., March 9,…
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Regulatory
X-Bolt Orthopedics Announces FDA 510(k) Clearance for Pro-X1™ Trochanteric Nail
DUBLIN, March 7, 2023 /PRNewswire/ — X-Bolt, an emerging innovator of orthopedic devices, is pleased to announce that its hip fracture solution,…
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Extremities
PeekMed® Unveils New Automated Orthopedic Solution for the US
BRAGA, Portugal, Feb. 21, 2023 /PRNewswire/ — PeekMed® sets new expectations for the orthopedic technology market with the launch of a web-based automated planning…
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Spine
Expanding Innovations, Inc. Announces FDA Approval of X-PAC Expandable Lateral Cage System
MOUNTAIN VIEW, Calif., Feb. 21, 2023 /PRNewswire/ — Expanding Innovations, Inc. (EI), a spinal implant company that designs NON-SCREW based expandable cage technology, announced…
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Spine
NuVasive Enhances C360 Portfolio with Expanded Indications for Modulus Cervical and Attrax Putty
Attrax Putty is now on-label for use with cervical Modulus interbody implants SAN DIEGO, Feb. 21, 2023 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the…
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Regulatory
Stryker’s Q Guidance System for cranial applications receives FDA clearance
Cranial Guidance Software offers surgeons robust imaging and guidance during cranial procedures February 17, 2023 KALAMAZOO, Mich.–(BUSINESS WIRE)–Stryker (NYSE:SYK), one…
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