← Product Code [GWO](/productcode/GWO) · K861822

# MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI (K861822)

_Valley Forge Scientific Corp. · GWO · Jul 11, 1986 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K861822

## Device Facts

- **Applicant:** Valley Forge Scientific Corp.
- **Product Code:** [GWO](/productcode/GWO.md)
- **Decision Date:** Jul 11, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **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/K861822](https://fda.innolitics.com/device/K861822)

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