510(k) K160466 ยท NKB Thoracolumbosacral Pedicle Screw System
Response 5.5 Spine System
| Applicant | OrthoPediatrics Corp., Warsaw IL, US |
| Decision | Substantially Equivalent, Mar 23, 2016 |
| Received | Feb 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160466
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.