METHA SHORT STEM HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

AESCULAP IMPLANT SYSTEM, INC.

The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Metha Short Stem Hip System.

Pre-market Notification Details

Device IDK080584
510k NumberK080584
Device Name:METHA SHORT STEM HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactKathy A Racosky
CorrespondentKathy A Racosky
AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeMEH  
Subsequent Product CodeKWY
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-03
Decision Date2008-05-09
Summary:summary

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