Device Dossier
SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement - Orthopaedic cement preparation/delivery kit
Device Dossier for SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement - Orthopaedic cement preparation/delivery kit (Orthopaedic cement…
- GMDN category: Orthopaedic cement preparation/delivery kit
Intended purpose
A single use system supplied with Bone cement and a collection of surgical instruments used for cement delivery such as injectors, delivery tubes, and mixing devices.
Functional description
SmartMix Cemvac is a vacuum mixing system syringe system pre-packed with bone cement powder and liquid. The device is single use only and reduces the exposure to monomer fumes during the preparation of Bone cement that indicated for the use of fixation of prosthesis to living bone arthroplasty procedures of joints in which infection by Gentamicin sensitive organisms is a potential risk. The Bone cement should be used with an appropriate prosthesis.