AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM

Shoulder Prosthesis, Reverse Configuration

Tornier SAS

The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis(tm) Ascent(tm) Flex Shoulder System.

Pre-market Notification Details

Device IDK140082
510k NumberK140082
Device Name:AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin,  FR 38330
ContactAymen Azaiez
CorrespondentAymen Azaiez
Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin,  FR 38330
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-13
Decision Date2014-07-18
Summary:summary

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