CONSERVE BIO FOAM SHELL

Prosthesis, Hip, Semi-constrained (metal Uncemented 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 Conserve Bio Foam Shell.

Pre-market Notification Details

Device IDK110029
510k NumberK110029
Device Name:CONSERVE BIO FOAM SHELL
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD Arlington,  TN  38002
ContactDanielle Mueller
CorrespondentDanielle Mueller
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD Arlington,  TN  38002
Product CodeKWA  
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-05
Decision Date2011-04-19
Summary:summary

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