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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K132774
Device Name PICCOLO COMPOSITE NAILING 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 Number888.3020
Classification Product Code
HSB  
Date Received09/05/2013
Decision Date 10/03/2013
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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