510(k) K253373 ยท JEY Plate, Bone
Southern Craniomaxillofacial (CMF) System
| Applicant | Southern Medical (Pty) , Ltd., Irene, ZA |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253373
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.