K241035 is an FDA 510(k) clearance for the PMT Posterior Cervical Stabilization System (PCSS). 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 June 25, 2024, 70 days after receiving the submission on April 16, 2024.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K241035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2024 |
| Decision Date | June 25, 2024 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW - System, Facet Screw Spinal Device |
| Device Class | - |