MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

MEDACTA INTERNATIONAL, SA

The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short Neck.

Pre-market Notification Details

Device IDK103189
510k NumberK103189
Device Name:MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego,  CA  92129
ContactNatalie J Kennel
CorrespondentNatalie J Kennel
MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego,  CA  92129
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-28
Decision Date2010-12-20
Summary:summary

NIH GUDID Devices

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