OZI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Internal Hinged Elbow Fixator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Double Internal Joint Stabilizer- Elbow (K231447) | Skeletal Dynamics, Inc. | 2023-12-15 |
| Internal Joint Stabilizer - Elbow (K223318) | Skeletal Dynamics, Inc. | 2023-05-10 |
| Internal Joint Stabilizer - Elbow (K153208) | Skeletal Dynamics, LLC | 2015-12-31 |
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