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FDA 510(k)

GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE

K-Number: K914000 · 1991-12-04

ApplicantDepuy, Inc.
Decision Date1991-12-04
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K914000. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE?

GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Depuy, Inc.. The 510(k) number is K914000.

When did GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE receive FDA 510(k) clearance?

GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE received FDA 510(k) clearance on 1991-12-04, under 510(k) number K914000.

Who is the listed applicant for GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE?

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 GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE?

The FDA product code for GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE is KWT.

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Other records listing Depuy, Inc. as applicant

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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: KWT)

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.

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH

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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