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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 K130061
Device Name PICCOLO COMPOSITE PLATE SYSTEM
Applicant
CarboFix Orthopedics , Ltd.
11 Ha'Hoshlim St.
Herzliya,  IL 46724
Applicant Contact YAEL RUBIN
Correspondent
CarboFix Orthopedics , Ltd.
11 Ha'Hoshlim St.
Herzliya,  IL 46724
Correspondent Contact YAEL RUBIN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/10/2013
Decision Date 02/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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