510(k) K213659 · OWI Bone Fixation Cerclage, Sublaminar
LigaPASS 2.0 Ligament Augmentation System
| Applicant | Medicrea International SA, Rillieux-La-Pape, FR |
| Decision | Substantially Equivalent, May 24, 2022 |
| Received | Nov 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213659
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.