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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K201251
Device Name CarboClear Navigated Instruments
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 Number882.4560
Classification Product Code
OLO  
Date Received05/11/2020
Decision Date 08/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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