← Product Code [FYI](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI) · K801072

# STRAITH NASAL SPLINT (K801072)

_Surgical Technology Laboratories, Inc. · FYI · Jun 17, 1980 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K801072

## Device Facts

- **Applicant:** Surgical Technology Laboratories, Inc.
- **Product Code:** [FYI](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI.md)
- **Decision Date:** Jun 17, 1980
- **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/K801072](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYI/K801072)

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