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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calcium salt bone void filler, drillable, non-screw augmentation
Regulation Description Resorbable calcium salt bone void filler device.
Definition To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.
Product CodeOIS
Regulation Number 888.3045
Device Class 2


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