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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filler, bone void, nonalterable compound for cranioplasty
Regulation Description Preformed nonalterable cranioplasty plate.
Definition A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material.
Product CodePJN
Regulation Number 882.5330
Device Class 2

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