21 CFR 872.4880 — Wire, Fixation, Intraosseous
Dental (DE) · Subpart E—Surgical Devices · § 872.4880
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DZK | Wire, Fixation, Intraosseous | 2 | 2 | Implant |
| DZL | Screw, Fixation, Intraosseous | 2 | 80 | Implant |
