DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Duraloc Cementless Acetabular Cup System.

Pre-market Notification Details

Device IDK961186
510k NumberK961186
Device Name:DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactSally Foust
CorrespondentSally Foust
DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-26
Decision Date1996-09-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295019732 K961186 000
10603295019725 K961186 000
10603295019718 K961186 000
10603295019701 K961186 000
10603295019695 K961186 000

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