DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM

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

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Asr Xl Modular Acetabular Cup System.

Pre-market Notification Details

Device IDK080991
510k NumberK080991
Device Name:DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactDawn Sinclair
CorrespondentDawn Sinclair
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeKWA  
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-07
Decision Date2008-07-02
Summary:summary

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