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FDA 510(k)

ANATOMICAL SHOULDER KEELED GLENOID

K-Number: K051623 · 2005-07-19

ApplicantZimmer GmbH
Decision Date2005-07-19
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANATOMICAL SHOULDER KEELED GLENOID is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2005-07-19 under 510(k) number K051623. 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 ANATOMICAL SHOULDER KEELED GLENOID?

ANATOMICAL SHOULDER KEELED GLENOID is a medical device that received FDA 510(k) clearance on 2005-07-19. The listed applicant is Zimmer GmbH. The 510(k) number is K051623.

When did ANATOMICAL SHOULDER KEELED GLENOID receive FDA 510(k) clearance?

ANATOMICAL SHOULDER KEELED GLENOID received FDA 510(k) clearance on 2005-07-19, under 510(k) number K051623.

Who is the listed applicant for ANATOMICAL SHOULDER KEELED GLENOID?

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

What is the FDA product code for ANATOMICAL SHOULDER KEELED GLENOID?

The FDA product code for ANATOMICAL SHOULDER KEELED GLENOID is KWS.

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Other records listing Zimmer GmbH 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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