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FDA 510(k)

DEPUY GLOBAL AP SHOULDER SYSTEM

K-Number: K060874 · 2006-06-28

ApplicantDePuy Orthopaedics, Inc.
Decision Date2006-06-28
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY GLOBAL AP SHOULDER SYSTEM 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 2006-06-28 under 510(k) number K060874. 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 AP SHOULDER SYSTEM?

DEPUY GLOBAL AP SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2006-06-28. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K060874.

When did DEPUY GLOBAL AP SHOULDER SYSTEM receive FDA 510(k) clearance?

DEPUY GLOBAL AP SHOULDER SYSTEM received FDA 510(k) clearance on 2006-06-28, under 510(k) number K060874.

Who is the listed applicant for DEPUY GLOBAL AP SHOULDER SYSTEM?

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 AP SHOULDER SYSTEM?

The FDA product code for DEPUY GLOBAL AP SHOULDER SYSTEM is KWS.

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Other records listing DePuy Orthopaedics, 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.

K262130ATTUNE Revision Knee SystemK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK210167DELTA XTEND Reverse Shoulder SystemK203167DePuy Corail AMT Hip Prosthesis

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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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