← Product Code [FYI](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI) · K821178

# ETHICON EXTERNAL FIXATION WIRE (K821178)

_ETHICON, Inc. · FYI · Jun 11, 1983 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K821178

## Device Facts

- **Applicant:** ETHICON, Inc.
- **Product Code:** [FYI](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI.md)
- **Decision Date:** Jun 11, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3250
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K821178](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K821178)

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