K231145 is an FDA 510(k) clearance for the Axis Anterior Cervical Plate System. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Southern Medical (Pty) , Ltd. (Irene, ZA). The FDA issued a Cleared decision on June 13, 2023, 53 days after receiving the submission on April 21, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K231145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2023 |
| Decision Date | June 13, 2023 |
| Days to Decision | 53 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 |