21 C.F.R. § 888.3000 Bone cap.
Title 21 - Food and Drugs
(a) Identification. A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §888.9. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, 2001]
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices
§ 888.3000 Bone cap.
