510(k) K130825 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
AZURE ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, May 7, 2013 |
| Received | Mar 26, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2014 | Orthofix, Inc Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only
The Azure Anterior Cervical Plate System is a temporary implant, intended for an Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.