Orthopedic devices; classification for the resorbable calcium salt bone void filler device. Final rule.
The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.
D001843:Bone Cements / Q000145:classification*; D017610:Calcium Compounds / Q000145:classification*; D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D009984:Orthopedic Fixation Devices / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration
D001843:Bone Cements; D017610:Calcium Compounds