Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Orthotech Pty Ltd - Metal-polymer composite spinal fusion cage
ARTG entry for
Medical Device Included Class IIb
Orthotech Pty Ltd
PO Box 203,ALBION, QLD, 4010
ARTG Start Date
Medical Device Class IIb
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
HumanTech Germany GmbH
, Steinenbronn, 71144
1. Metal-polymer composite spinal fusion cage
Single Device Product
61230 Metal-polymer composite spinal fusion cage
Intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically
due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically
designed as a small, hollow and/or porous, threaded or fenestrated cage (of several geometric forms) and
is a composite of non-bioabsorbable synthetic polymer and metal, e.g. PEEK and titanium (Ti), that is
implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient
space for bone fusion to occur.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:59:28 AEDT
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