510(k) K222105 ยท NKB Thoracolumbosacral Pedicle Screw System
RESPONSE 5.5/6.0 Cannulated Screw System
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 23, 2023 |
| Received | Jul 18, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K222105
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.