510(k) K221050 ยท OUR Sacroiliac Joint Fixation
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
| Applicant | Aegis Spine, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Jun 30, 2022 |
| Received | Apr 11, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221050
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.