510(k) K181978 · NKB Thoracolumbosacral Pedicle Screw System
Zenius, Iliad and Kora Spinal Fixation Systems
| Applicant | Medyssey USA, Inc., Elk Grove Village IL, US |
| Decision | Substantially Equivalent, Aug 13, 2018 |
| Received | Jul 24, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181978
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.