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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K254045
Device Name CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw 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 Number888.3075
Classification Product Code
NKG  
Date Received12/17/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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