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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 the device name listed in this FDA 510(k) record. The listed applicant is Xelite Biomed , Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) 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. The listed applicant is Xelite Biomed , Ltd.. The 510(k) number is K243537.

When did XeliteMed VertehighFix High Viscosity Spinal Bone Cement System receive FDA 510(k) clearance?

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

Who is the listed applicant for XeliteMed VertehighFix High Viscosity Spinal Bone Cement System?

The FDA 510(k) record lists Xelite Biomed , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07301749A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression FracturesRECRUITINGNCT07665424Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container SystemRECRUITING

Other records listing Xelite Biomed , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251896XeliteMed SuperM-Fix Spinal Bone CementK241775XeliteMed VertehighFix High Viscosity Spinal Bone Cement

Related Devices (Code: NDN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHypreventionK231340Renova Spine Balloon CatheterBiopsybell S.R.L.

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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