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FDA 510(k)

DEPUY POROUS COATED GLOBAL SHOULDER

K-Number: K943300 · 1994-10-31

ApplicantDepuy, Inc.
Decision Date1994-10-31
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DEPUY POROUS COATED GLOBAL SHOULDER is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1994-10-31 under 510(k) number K943300. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DEPUY POROUS COATED GLOBAL SHOULDER?

DEPUY POROUS COATED GLOBAL SHOULDER is a medical device that received FDA 510(k) clearance on 1994-10-31. The listed applicant is Depuy, Inc.. The 510(k) number is K943300.

When did DEPUY POROUS COATED GLOBAL SHOULDER receive FDA 510(k) clearance?

DEPUY POROUS COATED GLOBAL SHOULDER received FDA 510(k) clearance on 1994-10-31, under 510(k) number K943300.

Who is the listed applicant for DEPUY POROUS COATED GLOBAL SHOULDER?

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

What is the FDA product code for DEPUY POROUS COATED GLOBAL SHOULDER?

The FDA product code for DEPUY POROUS COATED GLOBAL SHOULDER is KWS.

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Other records listing Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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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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