V-Mix 02

Trade Name

V-Mix 03

Device Name

V-Mix 02

V-Mix

Model / Reference

800047

Primary DI / UDI-DI

08058964724625

Basic UDI-DI

0805896472kitLK, 805896472kit3W

EMDN Code

P099002 Orthopaedic cement preparation and application devices and kits

Device Class

Class I

Class III

Medical Purpose

V-MIX 02 is a procedure pack intended for preparation and delivery of V-FAST, a radiopaque bone cement for dedicated use, specifically formulated for the execution of vertebroplasty or percutaneous kyphoplasty procedures.

The procedure pack is intended for preparation and delivery of radiopaque bone cement for dedicated use, specifically formulated for the execution of vertebroplasty or percutaneous kyphoplasty procedures.

EUDAMED SRN

IT-PR-000041137

• V-Mix 02

  Class I

  CE/MDR

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  Class I

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  Class II

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  Class II

  CE/MDD FDA 510(k) K252443 Active Cleared 15 Sep 2025

• V-Steady, V-Fast Bone Cement

  Class II

  CE/MDD FDA 510(k) K150408 Active Cleared 14 Dec 2015

• G3 40 Radiopaque Bone Cement

  Class II

  CE/MDD FDA 510(k) K193061 Active Cleared 19 Mar 2020

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