OSN
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Software For Diagnosis/Treatment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ENOS Software Guided External Fixation System (K253764) | Disior, Ltd. | 2026-02-26 |
| Acute QC Strut and Components (K221792) | Smith & Nephew, Inc. | 2022-08-25 |
| Deformity Analysis and Correction Software (DACS) and Instrumentation (K180539) | Arrowhead Medical Device Technologies, LLC | 2018-08-13 |
| ORTHOHUB EXTERNAL FIXATOR SOFTWARE (K140550) | Orthohub, Inc. | 2014-08-25 |
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