Summary for ARTG Entry:
Signature Orthopaedics Pty Ltd - Prosthetic joint implantation kit
ARTG entry for
Medical Device Included Class IIa
Signature Orthopaedics Pty Ltd
7 Sirius Road,LANE COVE WEST, NSW, 2066
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.
Signature Orthopaedics Europe Ltd
14 Herbert Street Dublin 2
1. Prosthetic joint implantation kit
Single Device Product
44742 Prosthetic joint implantation kit
A collection of instruments used for cutting and forming bone to allow and assist with the implantation of a
joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors,
rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g. hip,
knee, shoulder, ankle, or elbow).
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:12:17 AEDT
This is not an ARTG Certificate document.
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