510(k) K260216 · NKB Thoracolumbosacral Pedicle Screw System
CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Apr 21, 2026 |
| Received | Jan 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260216
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.