Device Dossier
Bone graft delivery kit
Device Dossier for Bone graft delivery kit (Bone graft delivery kit, Class IIa, sponsor DePuy Synthes). ARTG record, intended purpose, GMDN category —…
- GMDN category: Bone graft delivery kit
Intended purpose
A collection of devices intended to be used to prepare bone graft material during an orthopaedic surgical procedure. It includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and premixing of bone marrow, autologous blood and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and/or their delivery to the surgical site. This is a single-use device.