Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4880](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4880) → DZK — Wire, Fixation, Intraosseous

# DZK · Wire, Fixation, Intraosseous

_Dental · 21 CFR 872.4880 · Class 2_

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

## Overview

- **Product Code:** DZK
- **Device Name:** Wire, Fixation, Intraosseous
- **Regulation:** [21 CFR 872.4880](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4880)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **Implant:** yes

## Identification

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

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K092530](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZK/K092530.md) | SPRYTIE, MODELS ST001, ST002 AND ST003 | Russell B. Walther | Apr 2, 2010 | SESE |
| [K022821](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZK/K022821.md) | ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E | Ideatrics, Inc. | Nov 15, 2002 | SESE |

## Top Applicants

- Ideatrics, Inc. — 1 clearance
- Russell B. Walther — 1 clearance

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

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