510(k) K232141 ยท NKB Thoracolumbosacral Pedicle Screw System
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 16, 2023 |
| Received | Jul 18, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232141
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.