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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K200519
Device Name CarboClear® II Pedicle Screw System
Applicant
CarboFix Orthopedics Ltd.
11 Ha'hoshlim St.
Herzeliya,  IL 4672411
Applicant Contact Hila Wachsler-Avrahami
Correspondent
CarboFix Orthopedics Ltd.
11 Ha'hoshlim St.
Herzeliya,  IL 4672411
Correspondent Contact Hila Wachsler-Avrahami
Regulation Number888.3070
Classification Product Code
NKB  
Date Received03/02/2020
Decision Date 04/30/2020
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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