← Product Code [GXN](/productcode/GXN) · K254222

# PRIMARY (CP.A.B.C.D); PRIMARY (UP.A.B.C.D); PRIMARY-Z (PS.A.B.C.D); PRIMARY-Z (PSS.A.B.C.D); PRIMARY-Z (PSD.A.B.C.D); PRIMARY-O (OR.A.B.C.D); PRIMARY-O (ORS.A.B.C.D); PRIMARY-O (ORD.A.B.C.D) (K254222)

_Cusmedi Co., Ltd. · GXN · Nov 6, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K254222

## Device Facts

- **Applicant:** Cusmedi Co., Ltd.
- **Product Code:** [GXN](/productcode/GXN.md)
- **Decision Date:** Nov 6, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5330
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot 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/K254222](https://fda.innolitics.com/device/K254222)

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