510(k) K221399 · PEK Spinous Process Plate
ZIP MIS Interspinous Fusion System
| Applicant | Aurora Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 8, 2022 |
| Received | May 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221399
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.