← Product Code [DYX](/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX) · K863799

# JAW FIXATION ASSEMBLY (K863799)

_Medical Products & Research, Inc. · DYX · Oct 14, 1986 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX/K863799

## Device Facts

- **Applicant:** Medical Products & Research, Inc.
- **Product Code:** [DYX](/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX.md)
- **Decision Date:** Oct 14, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4600
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX/K863799](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX/K863799)

**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