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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spinal vertebral body replacement device
510(k) Number K192214
Device Name CarboClear VBR 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 Number888.3060
Classification Product Code
MQP  
Date Received08/15/2019
Decision Date 10/11/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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