510(k) K180754 ยท NKB Thoracolumbosacral Pedicle Screw System
C-Zero Pedicle Screw System, Freedom Pedicle Screw System
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Dec 7, 2018 |
| Received | Mar 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180754
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.