Surgical devices · 21 CFR 872 Subpart E
Intraosseous Fixation Wire
FDA device type “Wire, Fixation, Intraosseous”.
- Companies listing it
- 76 makers
- Brands and models
- 6
- 510(k) clearances
- 20 in five years
- FDA name
- Wire, Fixation, Intraosseous
510(k) clearances per year, 1976–2026
Companies that list DZK
7 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| SYNTHES (USA) Products LLC | United States | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 7 | 2020 |
| Jabil Inc. | United States | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional | — | — |
| Banister Tool, Inc. | United States | Maker | ZS 906-2 BacFix TI Washer, Flat- 2MM · ZS 906-4 BacFix TI Washer, Flat -4MM | — | — |
| The Cretex Companies, Inc. | United States | Maker | BacFix Thoracolumber Fusion System | — | — |
| Highridge Medical, LLC | United States | Maker | — | — | — |
| TOMZ Corporation | United States | Maker | — | — | — |
| Medica Corporation | United States | Repacker / relabeler | Amphetamines (AMP) | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 2 Apr 2010 | K092530 | SPRYTIE, MODELS ST001, ST002 AND ST003 | Russell B. Walther |
| 15 Nov 2002 | K022821 | ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E | Ideatrics, Inc. |
Official records: FDA product classification for DZK · 21 CFR 872.4880.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026