GXJ · Punch, Skull
Neurology · 21 CFR 882.4750 · Class 1
Overview
| Product Code | GXJ |
|---|---|
| Device Name | Punch, Skull |
| Regulation | 21 CFR 882.4750 |
| Device Class | Class 1 |
| Review Panel | Neurology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
