← Product Code [DZL](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL) · K010527

# SYNTHES (USA) IMF SCREWS (K010527)

_Synthes (Usa) · DZL · Apr 25, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K010527

## Device Facts

- **Applicant:** Synthes (Usa)
- **Product Code:** [DZL](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL.md)
- **Decision Date:** Apr 25, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4880
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K010527](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K010527)

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