SMR TT Augmented Glenoid System

Shoulder Prosthesis, Reverse Configuration

Limacorporate S.p.A

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

Pre-market Notification Details

Device IDK191746
501k NumberK191746
Device Name:SMR TT Augmented Glenoid System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Limacorporate S.p.A via Nazionale 52 Villanova Di San Daniele Del Friuli,  IT 33038
ContactMichela Zanotto
CorrespondentStephen Peoples
Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne,  IN  46814
Product CodePHX  
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodeMBF
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-01
Decision Date2019-11-22

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