Summary for ARTG Entry:
Oceania Orthopaedics Pty Ltd - Diaphysis prosthesis
ARTG entry for
Medical Device Included Class IIb
Oceania Orthopaedics Pty Ltd
PO Box 89,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.
Luneburger Schanze 26
, Buxtehude, D 21614
1. Diaphysis prosthesis
Single Device Product
58084 Diaphysis prosthesis
To be implanted as a substitute for the diaphysis (shaft) of a humerus, femur or tibia. Intended to be
implanted for the long-term stabilization of segmental bone defects.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 11:59:46 AEDT
This is not an ARTG Certificate document.
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