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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 K160002
Device Name Piccolo Composite(R) Distal Volar Radius Plate System
Applicant
CARBOFIX ORTHOPEDICS LTD.
11 HA'HOSHLIM STREET
HERZELIYA,  IL 4672411
Applicant Contact Yael Rubin
Correspondent
CARBOFIX ORTHOPEDICS LTD.
11 HA'HOSHLIM STREET
HERZELIYA,  IL 4672411
Correspondent Contact Yael Rubin
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
KTT  
Date Received01/04/2016
Decision Date 03/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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