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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K222874
Device Name CarboClear Cervical Cage System, CarboClear Cervical VBR System
Applicant
Carbofix Orthpedics , Ltd.
11 Ha'Hoshlim St.
Herzliya,  IL 4672411
Applicant Contact Yael Rubin
Correspondent
Carbofix Orthpedics , Ltd.
11 Ha'Hoshlim St.
Herzliya,  IL 4672411
Correspondent Contact Yael Rubin
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
PLR  
Date Received09/22/2022
Decision Date 07/26/2023
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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