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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vertebroplasty compound, calcium based
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Definition THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.
Product CodeNUD
Regulation Number 888.3027
Device Class 2

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