510(k) K142939 ยท NKB Thoracolumbosacral Pedicle Screw System
Revolution Spinal Fixation System
| Applicant | Intelligent Implant Systems, LLC, Charlotte NC, US |
| Decision | Substantially Equivalent, Jan 13, 2015 |
| Received | Oct 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142939
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.