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FDA 510(k)

Augmented VaultLock Glenoid

K-Number: K210050 · 2021-06-07

ApplicantArthrex, Inc.
Decision Date2021-06-07
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Augmented VaultLock Glenoid is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2021-06-07 under approval number K210050. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Augmented VaultLock Glenoid?

Augmented VaultLock Glenoid is a medical device that received FDA 510(k) clearance on 2021-06-07. It is manufactured by Arthrex, Inc.. The 510(k) number is K210050.

When was Augmented VaultLock Glenoid approved by the FDA?

Augmented VaultLock Glenoid received FDA 510(k) clearance on 2021-06-07, under approval number K210050.

What company makes Augmented VaultLock Glenoid?

Augmented VaultLock Glenoid is manufactured by Arthrex, Inc..

What is the FDA product code for Augmented VaultLock Glenoid?

The FDA product code for Augmented VaultLock Glenoid is KWS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.