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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 K952928
Device Name AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
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 Received06/26/1995
Decision Date 09/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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