XeliteMed VertehighFix High Viscosity Spinal Bone Cement System — Xelite Biomed , Ltd. (510(k) K243537)
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System — Xelite Biomed , Ltd. (510(k) K243537) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: XeliteMed VertehighFix High Viscosity Spinal Bone Cement System; Applicant: Xelite Biomed , Ltd.; Clearance track: 510(k).
| Device name | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System |
|---|---|
| Applicant | Xelite Biomed , Ltd. |
| Clearance track | 510(k) |
| Submission number | K243537 |
| Decision | Substantially Equivalent |
| Decision date | 2025-04-11 |
| Date received | 2024-11-15 |
| Product code | NDN |
| Device class | 2 |
| Medical specialty | Orthopedic |
| Applicant location | TW |
| Source | openFDA device |
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