510(k) K180179 · NKB Thoracolumbosacral Pedicle Screw System
Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Aug 24, 2018 |
| Received | Jan 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180179
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.