FDA Product Code
FDA Product Code OSN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253764 | ENOS Software Guided External Fixation System | Disior, Ltd. | 2026-02-26 | Traditional | PDF ↗ |
| K221792 | Acute QC Strut and Components | Smith & Nephew, Inc. | 2022-08-25 | Traditional | PDF ↗ |
| K180539 | Deformity Analysis and Correction Software (DACS) and Instrumentation | Arrowhead Medical Device Technologies, LLC | 2018-08-13 | Traditional | PDF ↗ |
| K140550 | ORTHOHUB EXTERNAL FIXATOR SOFTWARE | Orthohub, Inc. | 2014-08-25 | Traditional | PDF ↗ |
Product code OSN · Class II · Orthopedic. Data: openFDA.