Device Dossier
Surgical procedure kit, orthopaedic, bone cement preparation/delivery
Device Dossier for Surgical procedure kit, orthopaedic, bone cement preparation/delivery (Orthopaedic cement preparation/delivery kit, Class IIa, sponsor…
- GMDN category: Orthopaedic cement preparation/delivery kit
Intended purpose
The sterile and single-use device is intended for the extrusion of acrylic resins or bone void fillers prepared with a Tecres mixing device, named Shakit. The device is composed of a plastic syringe with luer-lok connection and a scraper ring, a handle, an extrusion screw, and a stainless steel delivery cannula with luer-lok connection.