Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3250](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3250) → FYI — Appliance, Facial Fracture, External

# FYI · Appliance, Facial Fracture, External

_General, Plastic Surgery · 21 CFR 878.3250 · Class 1_

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

## Overview

- **Product Code:** FYI
- **Device Name:** Appliance, Facial Fracture, External
- **Regulation:** [21 CFR 878.3250](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3250)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K871073](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K871073.md) | OMEGA BIVALVE NASAL SPLINTS | Omega Silicone, Inc. | May 11, 1987 | SESE |
| [K821178](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K821178.md) | ETHICON EXTERNAL FIXATION WIRE | ETHICON, Inc. | Jun 11, 1983 | SESE |
| [K801072](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K801072.md) | STRAITH NASAL SPLINT | Surgical Technology Laboratories, Inc. | Jun 17, 1980 | SESE |
| [K792106](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K792106.md) | CONPHAR O.R. HEAD COVER-STERILE | Conphar, Inc. | Nov 5, 1979 | SESE |

## Top Applicants

- Conphar, Inc. — 1 clearance
- ETHICON, Inc. — 1 clearance
- Omega Silicone, Inc. — 1 clearance
- Surgical Technology Laboratories, Inc. — 1 clearance

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

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