MasterLoc Stem: Lateralized Plus

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 Masterloc Stem: Lateralized Plus.

Pre-market Notification Details

Device IDK173267
510k NumberK173267
Device Name:MasterLoc Stem: Lateralized Plus
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
CorrespondentElizabeth Rose
Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington,  KY  40504
Product CodeLZO  
Subsequent Product CodeKWY
Subsequent Product CodeLPH
Subsequent Product CodeLZY
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-11
Decision Date2017-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630040715843 K173267 000
07630040715836 K173267 000
07630040715829 K173267 000
07630040715812 K173267 000
07630040715805 K173267 000
07630040715799 K173267 000
07630040715782 K173267 000
07630040715775 K173267 000
07630040715768 K173267 000

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