← Product Code [GWO](/productcode/GWO) · K262874

# CraniUS Plate (K262874)

_CraniUS, LLC · GWO · Sep 11, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262874

## Device Facts

- **Applicant:** CraniUS, LLC
- **Product Code:** [GWO](/productcode/GWO.md)
- **Decision Date:** Sep 11, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 882.5320
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/device/K262874](https://fda.innolitics.com/device/K262874)

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