Summary for ARTG Entry:
JOI Orthopaedics Pty Ltd - CarboFix Instrument Kits - Fixation system implantation kit, internal
ARTG entry for
Medical Device Included Class IIa
JOI Orthopaedics Pty Ltd
44 Iffla Street,South Melbourne, VIC, 3205
ARTG Start Date
Medical Device Class IIa
- 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 Instrument Kits - Fixation system implantation kit, internal
Medical device system
44759 Fixation system implantation kit, internal
A collection of instruments used for the placement of an internal fixation system into or onto bone or bones
that may involve internal fixation (e.g., bones of limbs, spine, pelvis, craniomaxillofacia). The instruments
include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws,
screwdrivers, guides, trials, impactors) that are specific to the internal fixation system applied.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 08:41:02 AEDT
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