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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement, Posterior Screw Augmentation
510(k) Number K190526
Device Name High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
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 Number888.3027
Classification Product Code
PML  
Subsequent Product Code
NKB  
Date Received03/04/2019
Decision Date 09/19/2019
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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