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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessory, system, external fixator, containing antimicrobial agent
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones. The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire.
Product CodeNJA
Regulation Number 888.3040
Device Class 2

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