Summary for ARTG Entry:
JOI Orthopaedics Pty Ltd - CarboFix - Piccolo Composite Plate System - Orthopaedic fixation plate,
ARTG entry for
Medical Device Included Class IIb
JOI Orthopaedics Pty Ltd
44 Iffla Street,South Melbourne, VIC, 3205
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.
CarboFix Orthopedics Ltd
11 Ha'hoshlim Street
, Herzeliya, 46724
1. CarboFix - Piccolo Composite Plate System - Orthopaedic fixation plate, non-biodegradable
Medical device system
46647 Orthopaedic fixation plate, non-biodegradable
An implantable sheet of firm material (continuous carbon fibre reinforced polymer) that is attached to
fractured bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from
stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes.
The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to
temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).
No Specific Conditions included on Record
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Produced at 09.11.2017 at 08:41:17 AEDT
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