SMR Hybrid Glenoid System

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

Limacorporate S.p.A.

The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Hybrid Glenoid System.

Pre-market Notification Details

Device IDK163397
510k NumberK163397
Device Name:SMR Hybrid Glenoid System
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant Limacorporate S.p.A. via Nazionale 52 Villanova Di San Daniele,  IT 33038
ContactMichela Zanotto
CorrespondentStephen Peoples
Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne,  IN  46814
Product CodeMBF  
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodePHX
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-05
Decision Date2017-06-29
Summary:summary

NIH GUDID Devices

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