510(k) K192915 ยท NKB Thoracolumbosacral Pedicle Screw System
GMA 2.0 Pedicle Screw System
| Applicant | Grafton Medical Alliance, Burr Ridge IL, US |
| Decision | Substantially Equivalent, Nov 13, 2019 |
| Received | Oct 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192915
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.