FDA 510(k)

XeliteMed SuperM-Fix Spinal Bone Cement

K-Number: K251896 · 2026-01-28

Decision Date2026-01-28

Product CodeNDN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

XeliteMed SuperM-Fix Spinal Bone Cement is a medical device manufactured by Xelite Biomed , Ltd.. It received FDA 510(k) clearance on 2026-01-28 under approval number K251896. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XeliteMed SuperM-Fix Spinal Bone Cement?

XeliteMed SuperM-Fix Spinal Bone Cement is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by Xelite Biomed , Ltd.. The 510(k) number is K251896.

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

XeliteMed SuperM-Fix Spinal Bone Cement received FDA 510(k) clearance on 2026-01-28, under approval number K251896.

What company makes XeliteMed SuperM-Fix Spinal Bone Cement?

XeliteMed SuperM-Fix Spinal Bone Cement is manufactured by Xelite Biomed , Ltd..

What is the FDA product code for XeliteMed SuperM-Fix Spinal Bone Cement?

The FDA product code for XeliteMed SuperM-Fix Spinal Bone Cement is NDN.

Other Devices by Xelite Biomed , Ltd.

K241775XeliteMed VertehighFix High Viscosity Spinal Bone Cement K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

Related Devices (Code: NDN)

K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical , Ltd. K160983Kyphon HV-R Bone CementMedtronic, Inc. K153296MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. K161114HIGH V+Teknimed Sas

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.