SMR 40MM GLENOSPHERE

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 40mm Glenosphere.

Pre-market Notification Details

Device IDK142139
510k NumberK142139
Device Name:SMR 40MM GLENOSPHERE
ClassificationShoulder Prosthesis, Reverse Configuration
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 CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-05
Decision Date2014-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033390103428 K142139 000
08033390103411 K142139 000
08033390103404 K142139 000
08033390103398 K142139 000
08033390103381 K142139 000
08033390103374 K142139 000
08033390103442 K142139 000

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