SMS Cementless Stem

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 Sms Cementless Stem.

Pre-market Notification Details

Device IDK201673
510k NumberK201673
Device Name:SMS Cementless Stem
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeLZO  
Subsequent Product CodeKWY
Subsequent Product CodeLZY
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-19
Decision Date2020-09-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630971292062 K201673 000
07630971292055 K201673 000
07630971292048 K201673 000
07630971292031 K201673 000
07630971292024 K201673 000
07630971292017 K201673 000
07630971292000 K201673 000
07630971291997 K201673 000

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