Device Dossier
Awl
Device Dossier for Awl (Awl, Class IIa, sponsor LMT Surgical). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
- GMDN category: Awl
Intended purpose
Pediguard is indicated for use during screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vetebral cortex perforation. It is specifically indicated for use in intraoperative electromyographic surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves.