DM Converter - TiN Coated

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

Medacta International S.A.

The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Dm Converter - Tin Coated.

Pre-market Notification Details

Device IDK211891
510k NumberK211891
Device Name:DM Converter - TiN Coated
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Medacta International S.A. Strada Regina Castel San Pietro,  CH CH-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2022-07-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630971256392 K211891 000
07630971256385 K211891 000
07630971256378 K211891 000
07630971256361 K211891 000
07630971256354 K211891 000
07630971256347 K211891 000

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