Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4500](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4500) → HBX — Instrument, Cranioplasty Material Forming

# HBX · Instrument, Cranioplasty Material Forming

_Neurology · 21 CFR 882.4500 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBX

## Overview

- **Product Code:** HBX
- **Device Name:** Instrument, Cranioplasty Material Forming
- **Regulation:** [21 CFR 882.4500](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4500)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBX](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBX)

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