510(k) K200523 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Biolign® Roto-Loc Cervical Plate System
| Applicant | Elite Surgical Supplies (Pty), Ltd., Pretoria, ZA |
| Decision | Substantially Equivalent, Apr 30, 2020 |
| Received | Mar 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200523
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.