K232023 is an FDA 510(k) clearance for the Momentum Spine. This device is classified as a Device, Sensing, Optical Contour.
Submitted by Momentum Health, Inc. (Montreal, CA). The FDA issued a Cleared decision on October 4, 2023, 89 days after receiving the submission on July 7, 2023.
This device falls under the Physical Medicine FDA review panel.
| 510(k) Number | K232023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2023 |
| Decision Date | October 04, 2023 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | LDK - Device, Sensing, Optical Contour |
| Device Class | - |