510(k) K160216 ยท NKB Thoracolumbosacral Pedicle Screw System
Revolution Spinal Fixation System
| Applicant | Intelligent Implant Systems, LLC, Charlotte NC, US |
| Decision | Substantially Equivalent, Apr 22, 2016 |
| Received | Jan 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160216
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.