← Product Code [GET](/submissions/SU/subpart-e%E2%80%94surgical-devices/GET) · K955174

# SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (K955174)

_Sodem Diffusion SA · GET · Jan 22, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GET/K955174

## Device Facts

- **Applicant:** Sodem Diffusion SA
- **Product Code:** [GET](/submissions/SU/subpart-e%E2%80%94surgical-devices/GET.md)
- **Decision Date:** Jan 22, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4820
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GET/K955174](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GET/K955174)

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