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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K133668
Device Name AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
Applicant
SHOULDER OPTIONS, INC.
100 E. SOUTH MAIN ST.
P.O. BOX 1458
WAXHAW,  NC  28173
Applicant Contact JOHN KAPITAN
Correspondent
SHOULDER OPTIONS, INC.
100 E. SOUTH MAIN ST.
P.O. BOX 1458
WAXHAW,  NC  28173
Correspondent Contact JOHN KAPITAN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/29/2013
Decision Date 03/03/2014
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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