Medtronic Sofamor Danek USA, Inc. · Class II · Cleared Aug 16, 2023
| K-number | K232141 |
| Device name | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product code | NKB |
| Device class | Class II |
| Decision date | Aug 16, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
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