Device Dossier

Needle, aspirating, single use

Device Dossier for Needle, aspirating, single use (Needle, aspirating, single use, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN…

Intended purpose

A manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler. May be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. Indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

TGA Public Summary