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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name spinal fusion system with 12-methacryloyloxydodecyl pyridinium bromide (c21h34brno2) coating
De Novo Number DEN220015
Device Name Orthobond Mariner Pedicle Screw System
Orthobond Coporation
1 deerpark dr, ste a
monmouth,  NJ  08852
Contact david nichols
Regulation Number888.3071
Classification Product Code
Date Received02/28/2022
Decision Date 04/05/2024
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Reclassification Order Reclassification Order
Type Direct