FDA 510(k)

Arthrex SwiveLock Anchors

K-Number: K192441 · 2019-10-17

Decision Date2019-10-17

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 2019-10-17 under approval number K192441. 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 2019-10-17. It is manufactured by Arthrex, Inc.. The 510(k) number is K192441.

When was Arthrex SwiveLock Anchors approved by the FDA?

Arthrex SwiveLock Anchors received FDA 510(k) clearance on 2019-10-17, under approval number K192441.

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)

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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.