Panels › Orthopedic › Product code OSN · Class 2
Software For Diagnosis/Treatment
Regulation 888.3030
1510(k)s in 12 months (4 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OSN
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 1 | 1 |
| Arrowhead Medical Device Technologies, LLC | 1 | 0 |
| Disior, Ltd. | 1 | 0 |
| Orthohub, Inc. | 1 | 0 |
| OrthoPediatrics Corp | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 26, 2026 | K253764 | ENOS Software Guided External Fixation System Disior, Ltd. | OSN |
| Aug 25, 2022 | K221792 | Acute QC Strut and Components Smith & Nephew, Inc. | OSN |
| Aug 13, 2018 | K180539 | Deformity Analysis and Correction Software (DACS) and Instrumentation Arrowhead Medical Device Technologies, LLC | OSN |
| Aug 25, 2014 | K140550 | ORTHOHUB EXTERNAL FIXATOR SOFTWARE Orthohub, Inc. | OSN |
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