510(k) K211712 · KWQ Appliance, Fixation, Spinal Intervertebral Body
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
| Applicant | Orthofix US, LLC, Lewisville TX, US |
| Decision | Substantially Equivalent, Feb 11, 2022 |
| Received | Jun 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211712
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.