Submission Details
| 510(k) Number | K251885 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2025 |
| Decision Date | July 10, 2025 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
K251885 is an FDA 510(k) clearance for the CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant, a System, Facet Screw Spinal Device, submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on July 10, 2025, 20 days after receiving the submission on June 20, 2025. This device falls under the Orthopedic review panel.
| 510(k) Number | K251885 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2025 |
| Decision Date | July 10, 2025 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW — System, Facet Screw Spinal Device |
| Device Class | — |