LDK
- Product code
- LDK
- Device name
- Device, Sensing, Optical Contour
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- Enforcement Discretion
- 510(k) clearances (last 3 years)
- 8
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K230463 | 2023-11-15 | Nsite, Inc. | NSite Scoliosis Assessment App | |
| K232023 | 2023-10-04 | Momentum Health, Inc. | Momentum Spine | FDA |
Official FDA classification page: LDK
Classification and pathway per current FDA publications. Data from openFDA (CC0).