K231447 is an FDA 510(k) clearance for the Double Internal Joint Stabilizer- Elbow. This device is classified as a Internal Hinged Elbow Fixator (Class II - Special Controls, product code OZI).
Submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on December 15, 2023, 211 days after receiving the submission on May 18, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. 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..
| 510(k) Number | K231447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2023 |
| Decision Date | December 15, 2023 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OZI - Internal Hinged Elbow Fixator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| 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. |