Internal Hinged Elbow Fixator
FDA product code OZI · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved.
3510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231447 | Double Internal Joint Stabilizer- ElbowOZI · Traditional | Skeletal Dynamics, Inc. | 12/15/2023SE |
| K223318 | Internal Joint Stabilizer - ElbowOZI · Traditional | Skeletal Dynamics, Inc. | 05/10/2023SE |
| K153208 | Internal Joint Stabilizer - ElbowOZI · Traditional | Skeletal Dynamics, LLC | 12/31/2015SE |