21 CFR 882.4500 — Instrument, Cranioplasty Material Forming
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4500
Identification
A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.
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 |
|---|---|---|---|---|
| HBX | Instrument, Cranioplasty Material Forming | 1 | 0 |
