510(k) K180249 ยท JEY Plate, Bone
OmniPore DUROMAX Surgical Implants
| Applicant | Matrix Surgical Holdings, LLC/Matrix Surgical USA, Atlanta GA, US |
| Decision | Substantially Equivalent, Oct 11, 2018 |
| Received | Jan 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180249
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.