Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

osseointegration holdings pty ltd - 58744 - leg internal-external prosthesis transcutaneous adaptor - osseointegration prosthetic limb (opl) system is a modular system destined solely for intramedullary transfemoral and transcutaneous bone fixation through which an exoprosthesis limb is directly connected to the remaining portion of the femur in above-knee amputees. the transcutaneous dual cone adapter is the component which passes transcutaneously connecting the stem to the external adapter

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

biomet 3i australia pty ltd - 58709 - collagen dental regeneration membrane - for periodontal and/or dental surgery procedures as a material for placement in the area of periodontal defects, dental implant, bone defect or ridge reconstruction to aid in wound healing post surgery. intended for use in oral surgical procedures as a resorbable membrane material used in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects;guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

osseointegration holdings pty ltd - 61229 - external lower-limb prosthesis adaptor - the oi lower limb coupling connector is intended for connecting the modular exoskeletal prosthetic components to the abutment components of intramedullary fixation already implanted in the lower limb of an amputee patient.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

osseointegration holdings pty ltd - 62249 - custom-made anatomy model/surgical guide kit - guides and biomodels manufactured by 3-d printing intended to assist in anatomical visualization, surgical treatment planning, for intraoperative dental and craniomaxillofacial surgical procedures

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

osseointegration holdings pty ltd - 15811 - training model, anatomical, - optimise surgical interventions by acting as an aid or reference to improve efficiency of pre-operative surgical plan, and to determine the correct sizing of the fixture(s) required for the surgical intervention.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

osseointegration holdings pty ltd - 60826 - custom-made orthopaedic surgical guide, non-sterile - the patient specific surgical guide (pssg) is a medical device designed to assist in the intraoperative orientation of implant components or indication of the required cut/drill lines to achieve a pre-determined osteotomy geometry. the intended function of the pssg includes physical interfacing with bone geometry for placement, outlining the desired cut-line, and/or guiding of surgical instruments (e.g. surgical drill, oscillating cutting saw). the pssg is indicated to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) where the attending physician requires additional guidance in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw).

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

osseointegration holdings pty ltd - 61229 - external lower-limb prosthesis adaptor - the opl clamp connector system (opl-cc) is a medical device intended to serve as a means of connecting external prosthetic limb components to the transcutaneous component of the opl implant system in the lower limb of an amputee patient.

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

dentsply sirona singapore pte ltd - dental - astra tech implant system™ can be used in all partially and totally edentulous situations suitable for treatment with dental implants. single-tooth replacements, partial and total fixed or detachable bridges and overdentures can be supported by the implants. the osseospeed™ 3.0 s implant product line shall only be used to replace maxillary laterals and mandibulary central and lateral incisors.

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

dentsply sirona singapore pte ltd - dental - intended for both one-and two-stage surgical procedures in the following situations and with the clinical protocols: replacing missing teeth in single or multiple unit applications in the mandible or maxilla -immediate placement in extraction sites and in situations with partially or completely healed alveolar ridge -especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective -immediate & early loading for all indications except in single tooth situations on implant shorter than 8mm or in soft bone (type iv)where implant stability may be difficult to obtain & immediate loading may not be appropriate. intended use for osseospeed ev3.0s is limited to placement of maxillary lateral incisors & mandibular incisors. osseospeed profile ev4.2&4.8 are to be used only together with profile ev restorative components,implant driver profile ev, radiographic implant guides profile ev & non-indexed prosthetic components within astra tech implant system ev.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 43167 - acetabular shell - titanium alloy acetabular shell multi-hole design with a number of holes increasing with shell diameter, screw holes will not accept screw hole plugs. design facilitates screw placement based on patient anatomy. osseo-ti porous titanium material facilitates tissue ingrowth and implant stability. intended for uncemented biological fixation. shell accommodates multiple bearing options. g7 osseo-ti titanium alloy acetabular shell for use with proper liner, modular head and femoral stem as a component of a total hip prosthesis. intended for both primary and revision applications. indications for use: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed. intended for uncemented biological fixation.