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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device software for diagnosis/treatment
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Product CodeOSN
Regulation Number 888.3030
Device Class 2

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