DEPUY SPA POROUS COATED PROXIMAL SLEEVE

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Spa Porous Coated Proximal Sleeve.

Pre-market Notification Details

Device IDK071059
510k NumberK071059
Device Name:DEPUY SPA POROUS COATED PROXIMAL SLEEVE
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Applicant DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactKathy Harris
CorrespondentKathy Harris
DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeKWZ  
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-16
Decision Date2007-11-09
Summary:summary

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