FDA 510(k)

Arthrex SwiveLock Anchors

K-Number: K171141 · 2017-05-04

Decision Date2017-05-04

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex SwiveLock Anchors is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2017-05-04 under approval number K171141. 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 Anchors?

Arthrex SwiveLock Anchors is a medical device that received FDA 510(k) clearance on 2017-05-04. It is manufactured by Arthrex, Inc.. The 510(k) number is K171141.

When was Arthrex SwiveLock Anchors approved by the FDA?

Arthrex SwiveLock Anchors received FDA 510(k) clearance on 2017-05-04, under approval number K171141.

What company makes Arthrex SwiveLock Anchors?

Arthrex SwiveLock Anchors is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SwiveLock Anchors?

The FDA product code for Arthrex SwiveLock Anchors is MAI.

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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.