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

acra regulatory services pty ltd - 32390 - drill bit, surgical - surgical instrument intended to be used during implantation of an orthopaedic prosthesis. this is a single use device intended to be sterilized prior to use.

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

acra regulatory services pty ltd - 35685 - fixation device, internal, wire - a single-use device for short-term or transient use to guide, hold or fix a device or instrument in place. this device can be supplied sterile or non-sterile

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

acra regulatory services pty ltd - 44054 - surgical procedure kit, orthopaedic, reusable - collection of reusable surgical instruments intended to be used to perform an orthopaedic surgical procedure

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

acra regulatory services pty ltd - 62546 - intraoperative bone pin/screw, sterile - positioning and alignment device?intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone or provide landmarks?during navigated orthopaedic surgical procedures.? devices?may be?wholly- or partially-threaded for screwing into bone, and may have other physical features in various shapes and sizes to enable fixation of surgical instruments or facilitate navigation measurements. these are supplied as single-use sterile or single use non-sterile devices.

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

acra regulatory services pty ltd - 58927 - orthopaedic prosthesis implantation instrument, single-use - single use, sterile surgical instruments intended to be used during implantation of an orthopaedic prosthesis

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

acra regulatory services pty ltd - 44788 - spinal implant facsimile - copy of a spinal interbody fusion prosthesis, or other implantable device used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions.

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

acra regulatory services pty ltd - 44054 - surgical procedure kit, orthopaedic, reusable - a collection of various surgical instruments, and the necessary materials to perform an orthopaedic surgical procedure.

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

acra regulatory services pty ltd - 62208 - electromyographic endotracheal tube electrode - single use sterile laryngeal lantern electrodes are intended to be attached to an endotracheal tube and positioned for continuous emg monitoring of the larynx during surgical procedures with recording and monitoring equipment

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

acra regulatory services pty ltd - 61089 - nerve-locating probe, single-use - single use sterile probes and surgical instruments consisting of insulated electrical conductor which have exposed tip or the outer cannula for stimulating/recording of bio potential signals, are intended to be used during surgery to detect or stimulate nerve action potentials and for tissue dissection.

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

acra regulatory services pty ltd - 47714 - subdermal needle electrode - single use sterile subdermal needle electrodes are intended to be inserted in the subderma, muscle or nerve tissue to sense bio-electric, emg or eeg signals distally, and to be connected to emg/eeg recording equipment