EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED

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

CENTERPULSE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Epsilon Metasul 32mm Acetabular Inserts, Standard And Hooded.

Pre-market Notification Details

Device IDK033634
510k NumberK033634
Device Name:EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
ContactAudrey Swearingen
CorrespondentAudrey Swearingen
CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeKWA  
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-19
Decision Date2004-09-15
Summary:summary

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