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 IDK030941
510k NumberK030941
Device Name:AEQUALIS REVERSED SHOULDER PROSTHESIS
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant TORNIER 7651 S. 700 WEST SUITE 105 Salt Lake City,  UT  84047 -7101
ContactDonald F Grabarz
CorrespondentDonald F Grabarz
TORNIER 7651 S. 700 WEST SUITE 105 Salt Lake City,  UT  84047 -7101
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-25
Decision Date2004-05-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03700386917158 K030941 000

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