AEQUALIS UNIVERSAL SHOULDER GLENOID

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

TORNIER

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

Pre-market Notification Details

Device IDK994393
510k NumberK994393
Device Name:AEQUALIS UNIVERSAL SHOULDER GLENOID
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-28
Decision Date2000-06-22
Summary:summary

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