Custom-made orthopaedic surgical guide, non-sterile

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
08-11-2019

Dostopno od:

Omni Melbourne

Razred:

Class I

Izdeluje:

Omni Melbourne 40-42 Isabella Street, Moorabbin, VIC, 3189 Australia

Terapevtsko območje:

60826 - Custom-made orthopaedic surgical guide, non-sterile

Terapevtske indikacije:

This is a device that contains 3 surgical guides that have been custom made, patient specific and single use as a result of being prepared via a 3-D printing technique using CAD/CAM technologies. These surgical guides have been specifically designed as an integral single-use device that are intended to be used for locating the anchor pins as part of customising the AuDentes prosthetic Bridge, guiding the osteotomy of the maxilla and/or mandible as well as implanting the dental prosthetic devices which permanently retain the bridge.

Status dovoljenje:

A

Datum dovoljenje:

2019-09-13

Opozorila o iskanju, povezana s tem izdelkom