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 IDK041873
510k NumberK041873
Device Name:AEQUALIS REVERSED SHOULDER PROSTHESIS
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant TORNIER ZIRST-161, RUE LAVOISIER Montbonnot,  FR 38330
ContactMireille Lemery
CorrespondentMireille Lemery
TORNIER ZIRST-161, RUE LAVOISIER Montbonnot,  FR 38330
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-12
Decision Date2004-08-25
Summary:summary

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