Cleared Traditional

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

K241775 · Xelite Biomed , Ltd. · Orthopedic

Sep 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K241775 is an FDA 510(k) clearance for the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, 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 September 18, 2024, 90 days after receiving the submission on June 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K241775 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2024
Decision Date	September 18, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF