510(k) K243537 ยท NDN Cement, Bone, Vertebroplasty
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
| Applicant | Xelite Biomed , Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Apr 11, 2025 |
| Received | Nov 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243537
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.