510(k) K181390 ยท NKB Thoracolumbosacral Pedicle Screw System
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 18, 2018 |
| Received | May 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181390
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.