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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device internal hinged elbow fixator
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved.
Product CodeOZI
Regulation Number 888.3030
Device Class 2

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