510(k) K222789 · PML Bone Cement, Posterior Screw Augmentation
VADER® Pedicle System, G21 Cement
| Applicant | Icotec AG, 9450 Altstaetten (Sg), CH |
| Decision | Substantially Equivalent, Jan 9, 2023 |
| Received | Sep 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2024 | Icotec Ag VADER pedicle system, torque wrench, Catalog Number 42-702 Open, Classified |
PML | None listed |
| Jan 10, 2024 | Icotec Ag VADER pedicle system, torque wrench, Catalog Number 42-703 Open, Classified |
PML | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.