21 CFR 872.4760 — Plate, Bone
Dental (DE) · Subpart E—Surgical Devices · § 872.4760
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JEY | Plate, Bone | 2 | 292 | Implant |
| MDL | Implant, Transmandibular | 2 | 2 | Implant |
| MQN | External Mandibular Fixator And/Or Distractor | 2 | 60 | Implant |
