XeliteMed SuperM-Fix Spinal Bone Cement

FDA 510(k) K251896 · Xelite Biomed , Ltd.

Substantially Equivalent

510(k) numberK251896

Submission

Device name
XeliteMed SuperM-Fix Spinal Bone Cement
Applicant
Xelite Biomed , Ltd.
New Taipei City, TW
Received
June 20, 2025
Decision date
January 28, 2026
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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K250637VCFix Spinal SystemNDN · Traditional Amber Implants05/30/2025SE
K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemNDN · Traditional Xelite Biomed , Ltd.04/11/2025SE
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
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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
K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemNDN · Traditional 04/11/2025SE
K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementNDN · Traditional 09/18/2024SE

Questions and answers

When was XeliteMed SuperM-Fix Spinal Bone Cement cleared by the FDA?

XeliteMed SuperM-Fix Spinal Bone Cement (K251896) received a 510(k) decision of Substantially Equivalent on January 28, 2026, 222 days after the submission was received.

What is the product code of K251896?

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