510(k) K170964 ยท NKB Thoracolumbosacral Pedicle Screw System
Zenius Spinal System
| Applicant | Medyssey USA, Inc., Elk Grove Village IL, US |
| Decision | Substantially Equivalent, Apr 26, 2017 |
| Received | Mar 31, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170964
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.