Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Fixation system, internal, spinal, bone screw
ARTG entry for
Medical Device Included Class IIb
Medtronic Australasia Pty Ltd
PO Box 945,NORTH RYDE BC, NSW, 1670
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.
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis, Tennessee, 38132
United States Of America
1. Fixation system, internal, spinal, bone screw
Medical device system
43257 Fixation system, internal, spinal, bone screw
Intended for correction and maintenance of multi-planar spinal deformities associated with severe,
progressive, and early-onset scoliosis. The device is designed to help attain spinal correction while
allowing continued skeletal growth.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:28:04 AEDT
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