K230840 is an FDA 510(k) clearance for the PMT Facet Fixation System, Lumbar (PMT FFS-LX). This device is classified as a System, Facet Screw Spinal Device.
Submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 19, 2023, 267 days after receiving the submission on March 27, 2023.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K230840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2023 |
| Decision Date | December 19, 2023 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW - System, Facet Screw Spinal Device |
| Device Class | - |