---
kind: "section"
citation: "21 C.F.R. § 882.5320"
title: "21"
number: "882.5320"
heading: "Preformed alterable cranioplasty plate."
url: "https://uscodex.org/cfr/21/882.5320"
---

# §882.5320. Preformed alterable cranioplasty plate.

- (a) **Identification.** A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.
- (b) **Classification.** Class II (performance standards).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.