Athena Modular MIS System - Bone-screw internal spinal fixation system, non-sterile

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Life Healthcare Pty Ltd

Class:

Class IIb

Manufactured by:

Osimplant Tibbi Malzemeler Medikal Ticaret Ltd Sirketi Mustafa Kemal Mahallesi 2133 Sokak No 4/2 Cankaya, Ankara, Turkey Turkey

Therapeutic area:

61325 - Bone-screw internal spinal fixation system, non-sterile

Therapeutic indications:

Spinal system intended for noncervical pedicle fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Authorization status:

A

Authorization date:

2020-05-28