Bone cap.

21 C.F.R. § 888.3000
in effectEffective: 2024-07-01
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(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.

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