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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K030941
Device Name AEQUALIS REVERSED SHOULDER PROSTHESIS
Applicant
Tornier
7651 S 700 W.
Suite 105
Midvale,  UT  84047
Applicant Contact DONALD F GRABARZ
Correspondent
Tornier
7651 S 700 W.
Suite 105
Midvale,  UT  84047
Correspondent Contact DONALD F GRABARZ
Regulation Number888.3660
Classification Product Code
PHX  
Date Received03/25/2003
Decision Date 05/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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