Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Delta Xtend Standard Humeral Cup - Reverse
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 Standard Humeral Cup is made out of Ultra High Molecular Weight polyethylene
(UHMWPE) and sits in the humeral stem and articulates with the glenosphere.
The Delta Xtend Standard Humeral Cup is one component of the DeltaXtend Reverse Shoulder Prosthesis
System and is intended for use in total shoulder replacement procedures in patients with non-functional
Size +3mm or +6mm or +9mm
Diameter (mm) 38-42
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:57:30 AEDT
This is not an ARTG Certificate document.
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