Clearance Summary
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System received FDA 510(k) clearance under submission number K243537, sponsored by Xelite Biomed , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-04-11.
- Submission: K243537
- Applicant / Sponsor: Xelite Biomed , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2025-04-11
Classification & Regulation
This clearance is catalogued under FDA product code NDN and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.