510(k) K180626 ยท NKB Thoracolumbosacral Pedicle Screw System
Pedimax II - Pedicular Screw Spinal System
| Applicant | Gm Dos Reis Industria E Comerico Ltda., Campinas, BR |
| Decision | Substantially Equivalent, Feb 1, 2019 |
| Received | Mar 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180626
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.