Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Orthotech Pty Ltd - Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
ARTG entry for
Medical Device Included Class IIb
Orthotech Pty Ltd
PO Box 203,ALBION, QLD, 4010
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.
Via Delle Nazioni 9
BUSSOLENGO VERONA, , 37012
1. Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Medical device system
61688 Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of
the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for
limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of
materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade
metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of
the implants such as screwdrivers or drills.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:58:45 AEDT
This is not an ARTG Certificate document.
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