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FDA 510(k)

DEPUY GLOBAL SHOULDER CROSSLINK GLENOID

K-Number: K052472 · 2005-10-06

ApplicantDePuy Orthopaedics, Inc.
Decision Date2005-10-06
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY GLOBAL SHOULDER CROSSLINK GLENOID is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2005-10-06 under 510(k) number K052472. 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 DEPUY GLOBAL SHOULDER CROSSLINK GLENOID?

DEPUY GLOBAL SHOULDER CROSSLINK GLENOID is a medical device that received FDA 510(k) clearance on 2005-10-06. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K052472.

When did DEPUY GLOBAL SHOULDER CROSSLINK GLENOID receive FDA 510(k) clearance?

DEPUY GLOBAL SHOULDER CROSSLINK GLENOID received FDA 510(k) clearance on 2005-10-06, under 510(k) number K052472.

Who is the listed applicant for DEPUY GLOBAL SHOULDER CROSSLINK GLENOID?

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

What is the FDA product code for DEPUY GLOBAL SHOULDER CROSSLINK GLENOID?

The FDA product code for DEPUY GLOBAL SHOULDER CROSSLINK GLENOID is KWS.

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Other records listing DePuy Orthopaedics, 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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