510(k) K210035 ยท OUR Sacroiliac Joint Fixation
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
| Applicant | Aegis Spine, Englewood CO, US |
| Decision | Substantially Equivalent, Feb 16, 2021 |
| Received | Jan 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210035
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.