OSN — Software For Diagnosis/Treatment Class II
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 | February 26, 2026 |
| K221792 | smith and nephew | Acute QC Strut and Components | August 25, 2022 |
| K180539 | arrowhead medical device technologies | Deformity Analysis and Correction Software (DACS) and Instrumentation | August 13, 2018 |
| K140550 | orthohub | ORTHOHUB EXTERNAL FIXATOR SOFTWARE | August 25, 2014 |