Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Delta Xtend Metaglene - Reverse shoulder
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class III
- 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.
Depuy France SAS
7 Allee Irene Joliot Curie
SAINT PRIEST, CEDEX, 69801
1. Reverse shoulder prosthesis
Single Device Product
33711 Reverse shoulder prosthesis
The Delta Xtend Metaglene is made out of titanium alloy and is coated in hydroxyapatite for cementless
fixation into the glenoid and allows attachment of the implanted glenosphere.
The Delta Xtend Metaglene is one component of the Delta Xtend Reverse Shoulder Prosthesis System
and is intended for use in total shoulder replacement procedures in patients with non-functional rotator
Nil variant (as 1 device) N/A
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:55:53 AEDT
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