GXL · Screwdriver, Skullplate
Neurology · 21 CFR 882.4900 · Class 1
Overview
| Product Code | GXL |
|---|---|
| Device Name | Screwdriver, Skullplate |
| Regulation | 21 CFR 882.4900 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws.
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 the limitations in § 882.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
