21 C.F.R. § 882.4750 Skull punch.
Title 21 - Food and Drugs
(a) Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means. (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 §882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under §882.4305. [44 FR 51730–51778, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
§ 882.4750 Skull punch.
