21 CFR 882.4750 — Punch, Skull
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4750
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXJ | Punch, Skull | 1 | 0 |
