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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spinal fusion system with 12-methacryloyloxydodecyl pyridinium bromide (c21h34brno2) coating
Definition A spinal fusion system with 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating is a rigid metallic implant system compromised of single or multiple components intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The device includes a 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body.
Product CodeQZY
Regulation Number 888.3071
Device Class 2

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