SMR Shoulder System

Prosthesis, Shoulder, Non-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 Shoulder System.

Pre-market Notification Details

Device IDK161476
510k NumberK161476
Device Name:SMR Shoulder System
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant Limacorporate S.p.A. Via Nazionale, 52 Villanova Di San Daniele Udine,  IT 33038
ContactSara Viel
CorrespondentStephen J. Peoples
Limacorporate S.p.A. Via Nazionale, 52 Villanova Di San Daniele Udine,  IT 33038
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-27
Decision Date2016-06-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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