Momentum Spine is an AI-enabled medical device from Momentum Health Inc. that the U.S. FDA cleared through 510(k) K232023 on October 4, 2023. Its lead review panel is Radiology and its primary product code is LDK (Device, Sensing, Optical Contour).
See also FDA-cleared AI radiology devices in 2023, all FDA AI clearances in 2023, top radiology AI devices.
Key facts
| Submission number | K232023 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Momentum Health Inc. |
| Lead review panel | Radiology |
| Primary product code | LDK — Device, Sensing, Optical Contour |
| Applicant (openFDA) | Momentum Health, Inc. |
| Applicant location | Montreal, CA |
| Device class | Class U |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Momentum Spine went through this pathway (K232023).
Product code LDK covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Momentum Health Inc. has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.