AEQUALIS SHOULDER SYSTEM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

TORNIER

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

Pre-market Notification Details

Device IDK063081
510k NumberK063081
Device Name:AEQUALIS SHOULDER SYSTEM
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier,  FR 38334
ContactMireille Lemery
CorrespondentMireille Lemery
TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier,  FR 38334
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-10
Decision Date2006-11-09
Summary:summary

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