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FDA 510(k)

Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor

K-Number: K250526 · 2025-03-14

ApplicantArthrex, Inc.
Decision Date2025-03-14
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-03-14 under approval number K250526. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor?

Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Arthrex, Inc.. The 510(k) number is K250526.

When was Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor approved by the FDA?

Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor received FDA 510(k) clearance on 2025-03-14, under approval number K250526.

What company makes Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor?

Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor?

The FDA product code for Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is MAI.

Related Clinical Trials

NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED NCT05753891 Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective) TERMINATED NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

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Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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