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FDA 510(k)

Arthrex VaultLock Glenoid

K-Number: K161108 · 2016-08-29

ApplicantArthrex, Inc.
Decision Date2016-08-29
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex 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 2016-08-29 under 510(k) number K161108. 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 Arthrex VaultLock Glenoid?

Arthrex VaultLock Glenoid is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Arthrex, Inc.. The 510(k) number is K161108.

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

Arthrex VaultLock Glenoid received FDA 510(k) clearance on 2016-08-29, under 510(k) number K161108.

Who is the listed applicant for Arthrex 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 Arthrex VaultLock Glenoid?

The FDA product code for Arthrex VaultLock Glenoid is KWS.

Other records listing Arthrex, Inc. as applicant

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.

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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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