← Product Code [GWO](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO) · K903485

# TITANIUM MESH (K903485)

_Ruggles Corp. · GWO · Feb 21, 1991 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K903485

## Device Facts

- **Applicant:** Ruggles Corp.
- **Product Code:** [GWO](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO.md)
- **Decision Date:** Feb 21, 1991
- **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/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K903485](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K903485)

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