De Novo Classifications
FDA submissions for De Novo Classifications in the Orthopedic (OR) review panel, including product codes and regulations.
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 |