DYNASTY BIOFOAM 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 Dynasty Biofoam Shell.

Pre-market Notification Details

Device IDK121544
510k NumberK121544
Device Name:DYNASTY BIOFOAM SHELL
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactYuan Li
CorrespondentYuan Li
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeKWA  
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-25
Decision Date2012-07-30
Summary:summary

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