Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Fixation system, internal, spinal, bone screw
ARTG entry for
Medical Device Included Class IIb
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
Signus Medizintechnik GmbH
Alzenau, , D-63755
1. Fixation system, internal, spinal, bone screw
Medical device system
43257 Fixation system, internal, spinal, bone screw
The pedicle screw and fixation rod system is indicated for stabilisation of the spine until stability has been
achieved in patients who have undergone surgical fusion of the spine. Indications for all pedicle screw
systems: Instability of the spine or deviations from the normal position of the spine, Fractures,
Postoperative or degenerative instability, Tumours and spondylodiscitis, Correction of Meyerding grade 1
spondylolisthesis, Disc prolapse, Stenoses of the lumbar spine, Disc resection, Abnormal
lordosis/kyphosis/scoliosis and Degenerative segmental disease. The system is furthermore indicated in
situations where external immobilisation by means of a plaster cast or splint is not possible.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:02:39 AEDT
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