K223318 is an FDA 510(k) clearance for the 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 May 10, 2023, 194 days after receiving the submission on October 28, 2022.
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 | K223318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2022 |
| Decision Date | May 10, 2023 |
| Days to Decision | 194 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. |