510(k) K201457 ยท NKB Thoracolumbosacral Pedicle Screw System
Auxein Brand Vertaux 5.5 mm Pedicle Screw System
| Applicant | Auxein Medical Private Limited/71164, Sonipat, IN |
| Decision | Substantially Equivalent, Apr 6, 2021 |
| Received | Jun 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201457
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.