K240085 is an FDA 510(k) clearance for the zLOCK Lumbar Facet Fixation System. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Zygofix , Ltd. (Misgav, IL). The FDA issued a Cleared decision on April 18, 2024, 98 days after receiving the submission on January 11, 2024.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K240085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2024 |
| Decision Date | April 18, 2024 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW - System, Facet Screw Spinal Device |
| Device Class | - |