Summary for ARTG Entry:
JOI Orthopaedics Pty Ltd - Piccolo Composite Nailing System - Fixation nail, intramedullary, arthrodesis
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. Piccolo Composite Nailing System - Fixation nail, intramedullary, arthrodesis
Medical device system
44854 Fixation nail, intramedullary, arthrodesis
A rod made of continuous carbon fibre reinforced polymer, which, when inserted into the intramedullary
canal of long bones (e.g., femur, tibia, humerus, talus, fibula, radius, ulna, glenoid), acts as an
immobilization device by holding the ends of a fractured or diseased bone together (i.e., in position) for the
purpose of fusion or arthrodesis (the operation of fixing a joint in a given position from which it cannot be
moved) in orthopaedic surgery. The device is used for traumatic repair or reconstructive procedures; it
includes screws to lock into place.
No Specific Conditions included on Record
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