510(k) K230774 · PML Bone Cement, Posterior Screw Augmentation
PERLA® TL System; TEKTONA® HV US Bone Cement
| Applicant | Spineart, Geneva, CH |
| Decision | Substantially Equivalent, Jun 23, 2023 |
| Received | Mar 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230774
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.