510(k) K223521 ยท OUR Sacroiliac Joint Fixation
ZESPIN SI Joint Fusion System
| Applicant | Aegis Spine, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Jan 20, 2023 |
| Received | Nov 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223521
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.