Cleared Traditional

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

K243537 · Xelite Biomed , Ltd. · Orthopedic

Apr 2025

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K243537 is an FDA 510(k) clearance for the XeliteMed VertehighFix High Viscosity Spinal Bone Cement System, 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 review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K243537 FDA.gov
FDA Decision	Cleared 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