MODIFIED AML + ACETABULAR CUP PROSTHESIS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Modified Aml + Acetabular Cup Prosthesis.

Pre-market Notification Details

Device IDK900891
510k NumberK900891
Device Name:MODIFIED AML + ACETABULAR CUP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactKenneth G Roberts
CorrespondentKenneth G Roberts
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-27
Decision Date1990-03-12

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