ONN
- Product code
- ONN
- Device name
- Intraoperative Orthopedic Joint Assessment Aid
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4560
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 18
FDA classification definition
Measurement and interpretation of orthopedic joint information.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K262253 | 2026-07-31 | Orthalign, Inc. | Lantern Knee Navigation Unit (406000-03);Lantern Hip summary |
| K253507 | 2026-06-02 | Orthalign, Inc. | Packaged Assembly, Reusable Navigation Unit; Lantern summary |
| K252524 | 2025-09-09 | Eventum Orthopaedics, Ltd. | Quadsense (Quadsense and Quadsense Pro) summary |
| K241298 | 2024-10-04 | Eventum Orthopaedics, Ltd. | QUADSENSE summary |
| K242616 | 2024-10-03 | Orthalign, Inc. | Lantern® Hip summary |
Official FDA classification page: ONN
Classification and pathway per current FDA publications. Data from openFDA (CC0).