FDA 510(k)

Arthrex SwiveLock Anchor

K-Number: K203495 · 2021-04-19

Decision Date2021-04-19

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex SwiveLock Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2021-04-19 under approval number K203495. 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 Anchor?

Arthrex SwiveLock Anchor is a medical device that received FDA 510(k) clearance on 2021-04-19. It is manufactured by Arthrex, Inc.. The 510(k) number is K203495.

When was Arthrex SwiveLock Anchor approved by the FDA?

Arthrex SwiveLock Anchor received FDA 510(k) clearance on 2021-04-19, under approval number K203495.

What company makes Arthrex SwiveLock Anchor?

Arthrex SwiveLock Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SwiveLock Anchor?

The FDA product code for Arthrex SwiveLock Anchor 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.