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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 K060988
Device Name TOTAL AND HEMI SHOULDER SYSTEM
Applicant
DVO EXTREMITY SOLUTIONS, LLC
P.O. BOX 205
DERBY,  CT  06418
Applicant Contact DINA WEISSMAN
Correspondent
DVO EXTREMITY SOLUTIONS, LLC
P.O. BOX 205
DERBY,  CT  06418
Correspondent Contact DINA WEISSMAN
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   MBF  
Date Received04/10/2006
Decision Date 12/06/2006
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
Recalls CDRH Recalls
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