Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 40805 - marker, image identification, manual - an object that is manually configured and physically placed within the field of view of a medical diagnostic imaging system, and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. typically, this device is a surgically invasive radiographic marker used as a radiographic guide to help verify a place where surgery is performed (e.g., starting point of pedicle preparation and screw shank insertion). this device is temporarily used during surgery (not implantable).

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 37150 - guide, - an instrument used to lead another object in its proper course. this device is used to allow gentle introduction or manoeuvring into difficult sites and insure the exact positioning of another object.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 44874 - graft guide - a device used to protect a graft during delivery to the site of implantation.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 64336 - bone-coring punch, single-use - a hand-held manual surgical instrument designed to cut out (core) sections of bone during surgery to cut through the bone, allowing that section to be removed. this is a single-use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 35788 - calliper, orthopaedic - a measuring surgical instrument consisting of two legs hinged at one extremity used to measure, e.g. the diameter or length of bone to determine the appropriate size of an implant such as a cross connector.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 47821 - disposable self-retaining retraction system hook - a surgical instrument designed as a retraction system hook that hooks around the margins of an incision and is mounted and locked into position to a frame-like mechanism.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 62547 - intraoperative bone pin/screw, non-sterile - a small non-sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure. this is a single-use device intended to be sterilized prior to use.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 62546 - intraoperative bone pin/screw, sterile - a small sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 46566 - neurophysiologic monitoring system - an assembly of mains electricity (ac-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 63819 - spinal guidewire - a flexible wire intended to facilitate percutaneous introduction of surgical devices (e.g., cannula) during spinal surgery.