ANTERIOR APPROACH HIP SURGERY INSTRUMENTS

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 Anterior Approach Hip Surgery Instruments.

Pre-market Notification Details

Device IDK102565
510k NumberK102565
Device Name:ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactGregory Neal
CorrespondentGregory Neal
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeKWA  
Subsequent Product CodeJDI
Subsequent Product CodeJDL
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-07
Decision Date2010-12-22
Summary:summary

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