Aequalis Fx2

Shoulder Prosthesis, Reverse Configuration

Tornier SAS

The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis Fx2.

Pre-market Notification Details

Device IDK152966
510k NumberK152966
Device Name:Aequalis Fx2
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin,  FR 38330
ContactJovila Dodi
CorrespondentJovila Dodi
Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin,  FR 38330
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-07
Decision Date2016-01-14
Summary:summary

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