510(k) K201079 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Aurora® Anterior Lumbar Plate Sytstem
| Applicant | Prism Surgical Design Pty , Ltd., Milton, AU |
| Decision | Substantially Equivalent, Aug 5, 2020 |
| Received | Apr 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201079
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.