510(k) K153428 ยท NKB Thoracolumbosacral Pedicle Screw System
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Jan 29, 2016 |
| Received | Nov 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153428
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2016 | Orthofix, Inc Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile. Terminated |
HXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.