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FDA 510(k)

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

K-Number: K241775 · 2024-09-18

ApplicantXelite Biomed , Ltd.
Decision Date2024-09-18
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XeliteMed VertehighFix High Viscosity Spinal Bone Cement is a medical device manufactured by Xelite Biomed , Ltd.. It received FDA 510(k) clearance on 2024-09-18 under approval number K241775. 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?

XeliteMed VertehighFix High Viscosity Spinal Bone Cement is a medical device that received FDA 510(k) clearance on 2024-09-18. It is manufactured by Xelite Biomed , Ltd.. The 510(k) number is K241775.

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

XeliteMed VertehighFix High Viscosity Spinal Bone Cement received FDA 510(k) clearance on 2024-09-18, under approval number K241775.

What company makes XeliteMed VertehighFix High Viscosity Spinal Bone Cement?

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

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

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

Other Devices by Xelite Biomed , Ltd.

K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement System K251896XeliteMed SuperM-Fix Spinal Bone Cement

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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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