De Novo Classifications
FDA submissions for De Novo Classifications in the Orthopedic (OR) review panel, including product codes, regulations, and recent device decisions.
Section range: § 888.3900
CFR Part: 888
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QZZ | Limb And Joint Salvage Device With Coating For Bacteria Reduction | 888.3900 | 2 | 2 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K252920 | ELEOS Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | Oct 15, 2025 |
| DEN210058 | ELEOSx Limb Salvage System | Onkos Surgical | Apr 5, 2024 |
