510(k) K243537
K243537 is an FDA 510(k) premarket notification submitted by Xelite Biomed , Ltd. for the device "XeliteMed VertehighFix High Viscosity Spinal Bone Cement System". The FDA issued a decision of Substantially Equivalent on April 11, 2025. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Xelite Biomed , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2025
- Date Received
- November 15, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Bone, Vertebroplasty
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type