K234036 is an FDA 510(k) clearance for the SONIK MONARK 100. This device is classified as a Manipulator, Plunger-like Joint.
Submitted by Neuro Spinal Innovation, Inc. (Mississauga, CA). The FDA issued a Cleared decision on February 15, 2024, 56 days after receiving the submission on December 21, 2023.
This device falls under the Physical Medicine FDA review panel.
| 510(k) Number | K234036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2023 |
| Decision Date | February 15, 2024 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | LXM - Manipulator, Plunger-like Joint |
| Device Class | - |