Powered simple cranial drills, burrs, trephines, and their accessories.

21 C.F.R. § 882.4310
in effectEffective: 2024-07-01
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(a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull. (b) Classification. Class II (performance standards).

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