OSNClass II
Software For Diagnosis/Treatment
21 CFR 888.3030 / Orthopedic
OSN is the FDA product code for Software For Diagnosis/Treatment, a class II device type, regulated under 21 CFR 888.3030. FDA's definition for this code reads: "Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- OSN
- Device name
- Software For Diagnosis/Treatment
- FDA definition
- Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
- Regulation
- 21 CFR 888.3030
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 2
Clearances, product code OSN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code OSN| Applicant | Clearances |
|---|---|
| Arrowhead Medical Device Technologies, LLC | 1 |
| Disior Oy | 1 |
| Orthohub, Inc. | 1 |
| Smith & Nephew, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.