GMK Primary Fixed Tibial Insert STD - Uncoated knee tibia prosthesis, polyethylene

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
09-11-2017

Dostopno od:

Medacta Australia Pty Ltd

Razred:

Class III

Izdeluje:

Medacta International SA Strada Regina 6874 Castel, San Pietro Switzerland

Terapevtsko območje:

33580 - Uncoated knee tibia prosthesis, polyethylene

Terapevtske indikacije:

The GMK Primary Standard Fixed Tibial Insert is manufactured from UHMWPE and is designed to be used with the GMK Primary femoral and fixed tibial components. The inlay clipping mechanism assures time-effective and safe implantation. GMK Standard Fixed Tibial Insert forms part of the GMK Primary Knee System that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

Status dovoljenje:

A

Datum dovoljenje:

2014-04-11

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