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FDA 510(k)

Arthrex SwiveLock Suture Anchor

K-Number: K191226 · 2019-06-11

ApplicantArthrex, Inc.
Decision Date2019-06-11
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex SwiveLock Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-06-11 under approval number K191226. 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 SwiveLock Suture Anchor?

Arthrex SwiveLock Suture Anchor is a medical device that received FDA 510(k) clearance on 2019-06-11. It is manufactured by Arthrex, Inc.. The 510(k) number is K191226.

When was Arthrex SwiveLock Suture Anchor approved by the FDA?

Arthrex SwiveLock Suture Anchor received FDA 510(k) clearance on 2019-06-11, under approval number K191226.

What company makes Arthrex SwiveLock Suture Anchor?

Arthrex SwiveLock Suture Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SwiveLock Suture Anchor?

The FDA product code for Arthrex SwiveLock 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

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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