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FDA 510(k)

MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)

K-Number: K883661 · 1989-02-08

ApplicantDepuy, Inc.
Decision Date1989-02-08
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K883661. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)?

MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Depuy, Inc.. The 510(k) number is K883661.

When did MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) receive FDA 510(k) clearance?

MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) received FDA 510(k) clearance on 1989-02-08, under 510(k) number K883661.

Who is the listed applicant for MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)?

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 MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)?

The FDA product code for MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) is LWJ.

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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: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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