21 CFR 882.4900 — Screwdriver, Skullplate
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4900
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXL | Screwdriver, Skullplate | 1 | 0 |
