510(k) K163011 ยท NKB Thoracolumbosacral Pedicle Screw System
PHA S1 Spinal System
| Applicant | Phamedica, Inc., Plainview NY, US |
| Decision | Substantially Equivalent, Jun 29, 2017 |
| Received | Oct 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163011
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.