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FDA 510(k)

Alliance Augmented Glenoid

K-Number: K193180 · 2020-02-24

ApplicantZimmer, Inc.
Decision Date2020-02-24
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Alliance Augmented Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2020-02-24 under 510(k) number K193180. 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 Alliance Augmented Glenoid?

Alliance Augmented Glenoid is a medical device that received FDA 510(k) clearance on 2020-02-24. The listed applicant is Zimmer, Inc.. The 510(k) number is K193180.

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

Alliance Augmented Glenoid received FDA 510(k) clearance on 2020-02-24, under 510(k) number K193180.

Who is the listed applicant for Alliance Augmented Glenoid?

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

What is the FDA product code for Alliance Augmented Glenoid?

The FDA product code for Alliance Augmented Glenoid is KWS.

Other records listing Zimmer, 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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