510(k) K151488 ยท NKB Thoracolumbosacral Pedicle Screw System
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Jul 7, 2015 |
| Received | Jun 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151488
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2016 | Orthofix, Inc Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512)
Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium). Terminated |
HXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.