510(k) K171082 ยท NKB Thoracolumbosacral Pedicle Screw System
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, May 5, 2017 |
| Received | Apr 11, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2017 | Orthofix, Inc Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx.
.A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.