510(k) K162134 ยท NKB Thoracolumbosacral Pedicle Screw System
ENNOVATE Spinal System
| Applicant | Aesculap Implant Systems, LLC, Center Valley PA, US |
| Decision | Substantially Equivalent, Dec 14, 2016 |
| Received | Aug 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162134
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.