← Product Code [GWO](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO) · K812951

# RION AUDIOMETER AA-67 (K812951)

_Rion Acoustic Instruments, Inc. · GWO · Nov 6, 1981 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K812951

## Device Facts

- **Applicant:** Rion Acoustic Instruments, Inc.
- **Product Code:** [GWO](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO.md)
- **Decision Date:** Nov 6, 1981
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K812951](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K812951)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com