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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2021-06-07 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K210050.

When did Augmented VaultLock Glenoid receive FDA 510(k) clearance?

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

Who is the listed applicant for Augmented VaultLock Glenoid?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Augmented VaultLock Glenoid?

The FDA product code for Augmented VaultLock Glenoid is KWS.

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: KWS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

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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