# Xelite Biomed, Ltd.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 3 (2024–2026): 3 510(k) clearances
- Product codes: NDN (3)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tecres S.P.A.: 1 (https://510kreport.com/company/tecres)

## Its most-cited devices
- K241775: XeliteMed VertehighFix High Viscosity Spinal Bone Cement (2024), cited by 2

## Recent decisions
- K251896: XeliteMed SuperM-Fix Spinal Bone Cement (Jan 28, 2026)
- K243537: XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (Apr 11, 2025)
- K241775: XeliteMed VertehighFix High Viscosity Spinal Bone Cement (Sep 18, 2024)

Source page: https://510kreport.com/company/xelite-biomed