Summary for ARTG Entry:
Medacta Australia Pty Ltd - Fixation system, internal, spinal, bone screw
ARTG entry for
Medical Device Included Class IIb
Medacta Australia Pty Ltd
Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066
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.
Medacta International SA
Strada Regina 6874 Castel
, San Pietro, 0
1. Fixation system, internal, spinal, bone screw
Single Device Product
43257 Fixation system, internal, spinal, bone screw
The M.U.S.T. Pedicle screws system devices are fixation devices intended for stabilization and to promote
bone fusion during the normal healing process following surgical correction of disorders of the spine.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:32:24 AEDT
This is not an ARTG Certificate document.
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