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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 K231280
Device Name CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement
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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
OLO   PML  
Date Received05/03/2023
Decision Date 07/03/2023
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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