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FDA 510(k)

Arthrex Self Punching SwiveLock Suture Anchors

K-Number: K222263 · 2022-08-26

ApplicantArthrex, Inc.
Decision Date2022-08-26
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Self Punching SwiveLock Suture Anchors is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-08-26 under approval number K222263. 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 Self Punching SwiveLock Suture Anchors?

Arthrex Self Punching SwiveLock Suture Anchors is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Arthrex, Inc.. The 510(k) number is K222263.

When was Arthrex Self Punching SwiveLock Suture Anchors approved by the FDA?

Arthrex Self Punching SwiveLock Suture Anchors received FDA 510(k) clearance on 2022-08-26, under approval number K222263.

What company makes Arthrex Self Punching SwiveLock Suture Anchors?

Arthrex Self Punching SwiveLock Suture Anchors is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Self Punching SwiveLock Suture Anchors?

The FDA product code for Arthrex Self Punching SwiveLock Suture Anchors 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 NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

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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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