XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

FDA 510(k) K243537 · Xelite Biomed , Ltd.

Substantially Equivalent

510(k) numberK243537

Submission

Device name
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
Applicant
Xelite Biomed , Ltd.
New Taipei City, TW
Received
November 15, 2024
Decision date
April 11, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NDN – Cement, Bone, Vertebroplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code NDN

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K251896XeliteMed SuperM-Fix Spinal Bone CementNDN · Traditional Xelite Biomed , Ltd.01/28/2026SE
K250637VCFix Spinal SystemNDN · Traditional Amber Implants05/30/2025SE
K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementNDN · Traditional Xelite Biomed , Ltd.09/18/2024SE
K232842Balloon Inflation SystemNDN · Traditional Ningbo Hicren Biotechnology Co., Ltd.02/29/2024SE
K240084V-STRUT® Vertebral ImplantNDN · Special Hyprevention02/09/2024SE
K231340Renova Spine Balloon CatheterNDN · Traditional Biopsybell S.R.L.10/30/2023SE
K221697Injection Pin (KIP(02031-02061) (03031-03061))NDN · Traditional Slk Ortho, LLC03/03/2023SE
K223294SpineJack® Expansion KitNDN · Traditional Stryker Instruments12/20/2022SE
K220131KYPHON VuE Bone CementNDN · Traditional Tecres S.P.A.04/18/2022SE
K211797TRACKER Plus Kyphoplasty SystemNDN · Traditional GS Medical Co., Ltd.10/28/2021SE

More from GS Medical Co., Ltd.

510(k)DeviceDecision
K251896XeliteMed SuperM-Fix Spinal Bone CementNDN · Traditional 01/28/2026SE
K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementNDN · Traditional 09/18/2024SE

Questions and answers

When was XeliteMed VertehighFix High Viscosity Spinal Bone Cement System cleared by the FDA?

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (K243537) received a 510(k) decision of Substantially Equivalent on April 11, 2025, 147 days after the submission was received.

What is the product code of K243537?

The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.