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FDA 510(k)

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

K-Number: K243537 · 2025-04-11

ApplicantXelite Biomed , Ltd.
Decision Date2025-04-11
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is a medical device manufactured by Xelite Biomed , Ltd.. It received FDA 510(k) clearance on 2025-04-11 under approval number K243537. 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 VertehighFix High Viscosity Spinal Bone Cement System?

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Xelite Biomed , Ltd.. The 510(k) number is K243537.

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

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System received FDA 510(k) clearance on 2025-04-11, under approval number K243537.

What company makes XeliteMed VertehighFix High Viscosity Spinal Bone Cement System?

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is manufactured by Xelite Biomed , Ltd..

What is the FDA product code for XeliteMed VertehighFix High Viscosity Spinal Bone Cement System?

The FDA product code for XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is NDN.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Xelite Biomed , Ltd.

K241775XeliteMed VertehighFix High Viscosity Spinal Bone Cement K251896XeliteMed SuperM-Fix Spinal Bone Cement

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

View on FDA Database →

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

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