HBX · Instrument, Cranioplasty Material Forming
Neurology · 21 CFR 882.4500 · Class 1
Overview
| Product Code | HBX |
|---|---|
| Device Name | Instrument, Cranioplasty Material Forming |
| Regulation | 21 CFR 882.4500 |
| Device Class | Class 1 |
| Review Panel | Neurology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
