DEPUY DURALOC 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 Acetabular Cup System.

Pre-market Notification Details

Device IDK972596
510k NumberK972596
Device Name:DEPUY DURALOC ACETABULAR CUP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactCheryl Hastings
CorrespondentCheryl Hastings
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 Received1997-07-11
Decision Date1997-11-12
Summary:summary

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