§ 888.3000. Bone cap.
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/us/cfr/t21/s§ 888.3000·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 888.3000
Bone cap.
Fed. Reg.×1
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