PROFEMUR TAPERED HIP STEM

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

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Profemur Tapered Hip Stem.

Pre-market Notification Details

Device IDK041114
510k NumberK041114
Device Name:PROFEMUR TAPERED HIP STEM
ClassificationProsthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactKatie Logerot
CorrespondentKatie Logerot
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeJDL  
Subsequent Product CodeJDI
Subsequent Product CodeKWA
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-28
Decision Date2004-05-28
Summary:summary

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