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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K980244
Device Name AEQUALIS SHOULDER PROSTHESIS
Applicant
Tornier
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Tornier
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received01/23/1998
Decision Date 08/23/1999
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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