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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion
Definition Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics.
Product CodeOKD
Device Class Humanitarian Device Exemption