MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C

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 - Quadra C.

Pre-market Notification Details

Device IDK083558
510k NumberK083558
Device Name:MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-02
Decision Date2009-03-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030802362 K083558 000
07630030802225 K083558 000
07630030802232 K083558 000
07630030802249 K083558 000
07630030802256 K083558 000
07630030802263 K083558 000
07630030802270 K083558 000
07630030802287 K083558 000
07630030802300 K083558 000
07630030802317 K083558 000
07630030802324 K083558 000
07630030802331 K083558 000
07630030802348 K083558 000
07630030802355 K083558 000
07630030802218 K083558 000

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