K230424 is an FDA 510(k) clearance for the Omnia Medical Coupler-A™ Anterior Lumbar Plate System. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Omnia Medical, LLC (Morgantown, US). The FDA issued a Cleared decision on April 12, 2023, 54 days after receiving the submission on February 17, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K230424 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2023 |
| Decision Date | April 12, 2023 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWQ - Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |