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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 K232341
Device Name CarboClear® 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 Received08/04/2023
Decision Date 10/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT02626624
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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