K243537 is an FDA 510(k) clearance for the XeliteMed VertehighFix High Viscosity Spinal Bone Cement System. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Xelite Biomed , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on April 11, 2025, 147 days after receiving the submission on November 15, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K243537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2024 |
| Decision Date | April 11, 2025 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN - Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |