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 "Vertebroplasty Needle Kit" is intended to introduce bone cement into the body during a vertebroplasty procedure. The kit is intended only to be used in combination with the Vertecem Vertebroplasty System, consisting of the i) Vertecem Mixing Kit (bone cement) and ii) Viscosafe Injection Kit (syringes).