Device Dossier
Surgical drill guide, single-use
Device Dossier for Surgical drill guide, single-use (Surgical drill guide, single-use, Class IIa, sponsor Zimmer Biomet). ARTG record, intended purpose,…
- GMDN category: Surgical drill guide, single-use
Intended purpose
A sterile hand-held surgical tubular device designed to simultaneously place, angle, and guide a rotating drill (i.e a surgical twist drill) on hard tissue (usually bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissues surfaces; it can have a handle at its proximal end for holding and manipulation, or it may be held by another device, e.g. locked in an orthopedic jig. The device can be used under fluoroscopic imaging and aligned to the specific anatomy, based on the patient's peroperative imaging. This is a single use device