DZK · Wire, Fixation, Intraosseous
Dental · 21 CFR 872.4880 · Class 2
Overview
| Product Code | DZK |
|---|---|
| Device Name | Wire, Fixation, Intraosseous |
| Regulation | 21 CFR 872.4880 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092530 | SPRYTIE, MODELS ST001, ST002 AND ST003 | Russell B. Walther | Apr 2, 2010 | SESE |
| K022821 | 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
- Russell B. Walther — 1 clearance
- Ideatrics, Inc. — 1 clearance
