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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, external fixator (with metallic invasive components)
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeNDK
Regulation Number 888.3040
Device Class 2

Device Problems
Electro-magnetic interference (EMI) 1
Total Device Problems 1

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