Skip to content

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

by Xelite Biomed, Ltd.

510(k) K241775

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

XeliteMed VertehighFix High Viscosity Spinal Bone Cement is a high-viscosity cement approved for the treatment of osteoporotic vertebral fractures. This device has undergone substantial equivalence with other products, meeting the requirements of Traditional spinal bone cement in terms of efficacy and safety.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241775 Date18 Sep 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NDN
FDA applicant
Xelite Biomed , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Xelite Biomed, Ltd.