AEQUALIS PRESS-FIT SHOULDER PROSTHESIS

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Press-fit Shoulder Prosthesis.

Pre-market Notification Details

Device IDK011942
510k NumberK011942
Device Name:AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant TORNIER RUE DOYEN GOSSE St. Ismier,  FR 38330
ContactIrene Gosset
CorrespondentIrene Gosset
TORNIER RUE DOYEN GOSSE St. Ismier,  FR 38330
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-21
Decision Date2001-07-13
Summary:summary

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