510(k) K213281 · NKB Thoracolumbosacral Pedicle Screw System
PASS LP Spinal System, CD Horizon Spinal System
| Applicant | Medicrea International SA, Rillieux-La-Pape, FR |
| Decision | Substantially Equivalent, Jan 5, 2022 |
| Received | Oct 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213281
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.