510(k) K200937 ยท NKB Thoracolumbosacral Pedicle Screw System
ACURA Stabilization System
| Applicant | Indius Medical Technologies Pvt. , Ltd., Pune, IN |
| Decision | Substantially Equivalent, Oct 26, 2020 |
| Received | Apr 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200937
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.