510(k) K182283 ยท NKB Thoracolumbosacral Pedicle Screw System
FUSE Pedicle Screw System
| Applicant | Black Box Medical, Midland TX, US |
| Decision | Substantially Equivalent, Oct 23, 2018 |
| Received | Aug 23, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182283
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.