OSN — Software For Diagnosis/Treatment Class II
FDA product code OSN covers "Software For Diagnosis/Treatment", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OSN
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253764 | Disior | ENOS Software Guided External Fixation System | Feb 26, 2026 |
| K221792 | Smith And Nephew | Acute QC Strut and Components | Aug 25, 2022 |
| K180539 | Arrowhead Medical Device Technologies | Deformity Analysis and Correction Software (DACS) and Instrumentation | Aug 13, 2018 |
| K140550 | Orthohub | ORTHOHUB EXTERNAL FIXATOR SOFTWARE | Aug 25, 2014 |