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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 K182015
Device Name Piccolo Composite® Plate System
Applicant
CarboFix Orthopedics Ltd.
11 Ha'hoshlim St.
herzeliya,  IL 4672411
Applicant Contact yael rubin
Correspondent
CarboFix Orthopedics Ltd.
11 Ha'hoshlim St.
herzeliya,  IL 4672411
Correspondent Contact yael rubin
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/27/2018
Decision Date 10/11/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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