MASTERSL FEMORAL STEM

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

LIMACORPORATE S.P.A.

The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Mastersl Femoral Stem.

Pre-market Notification Details

Device IDK140975
510k NumberK140975
Device Name:MASTERSL FEMORAL STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne,  IN  46814
ContactStephen Peoples
CorrespondentStephen Peoples
LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne,  IN  46814
Product CodeLZO  
Subsequent Product CodeJDI
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLPH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-16
Decision Date2014-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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