510(k) K193100 · NKB Thoracolumbosacral Pedicle Screw System
RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 24, 2020 |
| Received | Nov 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193100
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.