FDA 510(k) Clearance
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Top Stories
Smith+Nephew announces 510(k) clearance of its AETOS™ Shoulder System for anatomic and reverse shoulder replacement
LONDON, June 12, 2023 /PRNewswire/ — Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance from the…
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Regulatory
SMAIO Receives FDA 510(k) Clearance for Customized Surgery Planning Software Co-Developed with NuVasive
LYON, France, June 8, 2023–(BUSINESS WIRE)–Regulatory News – SMAIO (Software, Machines and Adaptative Implants in Orthopaedics – Euronext Growth Paris ISIN: FR0014005I80 / Ticker: ALSMA),…
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Recon
FX Receives 510k Clearance for Additional FX V135™ Shoulder System
The First-and-Only Interlocking Shoulder System with Intraoperative Options Between 135° and 145° for Reverse Total Shoulder Arthroplasty DALLAS, June 8, 2023 /PRNewswire/…
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Regulatory
Artelon, Inc.’s FlexBand®, FlexPatch®, and FlexBand Plus® earn FDA Clearance for Ligament Reinforcement
Clearance includes extra-articular ligaments in various joints and substantially increases addressable market MARIETTA, Ga., June 6, 2023 /PRNewswire/ — Artelon Inc., announced…
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Robotics
THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System
FREMONT, Calif., May 30, 2023 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that…
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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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