SMR Lateralized Connectors With Screws

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Limacorporate S.p.A.

The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Lateralized Connectors With Screws.

Pre-market Notification Details

Device IDK183042
510k NumberK183042
Device Name:SMR Lateralized Connectors With Screws
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant Limacorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele,  IT 33038
ContactRoberto Gabetta
CorrespondentStephen Peoples
Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne,  IN  46814
Product CodeKWS  
Subsequent Product CodeKWT
Subsequent Product CodeMBF
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-02
Decision Date2019-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033390152174 K183042 000
08033390153119 K183042 000

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