510(k) K210963 ยท NKB Thoracolumbosacral Pedicle Screw System
ENNOVATE Spinal System
| Applicant | Aesculap Implant Systems, LLC, Center Valley PA, US |
| Decision | Substantially Equivalent, Jul 19, 2021 |
| Received | Mar 31, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210963
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.