K232877 is an FDA 510(k) clearance for the FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System. This device is classified as a System, Facet Screw Spinal Device.
Submitted by K&J Consulting Corporation (Lansdale, US). The FDA issued a Cleared decision on December 13, 2023, 89 days after receiving the submission on September 15, 2023.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K232877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW - System, Facet Screw Spinal Device |
| Device Class | - |