---
kind: "section"
citation: "21 C.F.R. § 882.4750"
title: "21"
number: "882.4750"
heading: "Skull punch."
url: "https://uscodex.org/cfr/21/882.4750"
---

# §882.4750. Skull punch.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 882.9](/cfr/21/882.9.md). This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under [§ 882.4305](/cfr/21/882.4305.md).

## Notes

### Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]