510(k) K252885 ยท PML Bone Cement, Posterior Screw Augmentation
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
| Applicant | Astura Medical, Irving TX, US |
| Decision | Substantially Equivalent, Jan 22, 2026 |
| Received | Sep 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252885
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.