Device Dossier

Surgical instrument handle

Device Dossier for Surgical instrument handle (Surgical instrument handle, Class IIa, sponsor DePuy Synthes). ARTG record, intended purpose, GMDN…

Intended purpose

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw, dental implant or otherwise surgically functional; it does not include a torque-limiting function. The device is typically may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

TGA Public Summary