DYNASTY ACETABULAR SYSTEM

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 Dynasty Acetabular System.

Pre-market Notification Details

Device IDK070785
510k NumberK070785
Device Name:DYNASTY ACETABULAR SYSTEM
ClassificationProsthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactMatt Paul
CorrespondentMatt Paul
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeJDL  
Subsequent Product CodeJDI
Subsequent Product CodeKWA
Subsequent Product CodeLPH
Subsequent Product CodeMBL
CFR Regulation Number888.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-21
Decision Date2007-07-11

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