510(k) K130932 ยท NKB Thoracolumbosacral Pedicle Screw System
FIREBIRD SPINAL FIXATION SYSTEM
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Aug 7, 2013 |
| Received | Apr 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130932
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2015 | Orthofix, Inc ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.