AEQUALIS REVERSED SHOULDER PROSTHESIS

Shoulder Prosthesis, Reverse Configuration

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Reversed Shoulder Prosthesis.

Pre-market Notification Details

Device IDK100142
510k NumberK100142
Device Name:AEQUALIS REVERSED SHOULDER PROSTHESIS
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier,  FR 38334
ContactSeverien Bonneton
CorrespondentSeverien Bonneton
TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier,  FR 38334
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-19
Decision Date2010-05-06
Summary:summary

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