DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Corail Amt Dysplasia Hip Prosthesis.

Pre-market Notification Details

Device IDK070554
510k NumberK070554
Device Name:DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw,  IN  46581 -0988
ContactKathy Harris
CorrespondentKathy Harris
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw,  IN  46581 -0988
Product CodeKWA  
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-27
Decision Date2007-09-11
Summary:summary

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