SMR REVERSE SHOULDER 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 Reverse Shoulder System.

Pre-market Notification Details

Device IDK110598
510k NumberK110598
Device Name:SMR REVERSE SHOULDER SYSTEM
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake,  IN  46590 -696
ContactCheryl Hastings
CorrespondentCheryl Hastings
LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake,  IN  46590 -696
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-02
Decision Date2011-08-18
Summary:summary

NIH GUDID Devices

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