Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis

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

Tornier SAS

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

Pre-market Notification Details

Device IDK151293
510k NumberK151293
Device Name:Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant Tornier SAS 161 Rue Lavoisier Monbonnot Saint Martin,  FR 38334
ContactSeverine Bonneton
CorrespondentSeverine Bonneton
Tornier SAS 161 Rue Lavoisier Monbonnot Saint Martin,  FR 38334
Product CodeKWS  
Subsequent Product CodeHSD
Subsequent Product CodeKWT
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-15
Decision Date2015-09-24
Summary:summary

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