510(k) K213266 ยท PEK Spinous Process Plate
Inspan ScrewLES Fusion System
| Applicant | Lespine Innovations, LLC, Malden MA, US |
| Decision | Substantially Equivalent, Dec 3, 2021 |
| Received | Sep 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213266
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.