Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Delta Xtend Cemented Monobloc Humeral Stem
- Reverse shoulder prosthesis
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 Cemented Monobloc Humeral Stem is a one-piece humeral component made out of
polished cobalt chromium. It is uncoated and requires cemented fixation.
The Delta Xtend Monobloc Humeral Cemented Stem is one component of the DeltaXtend Reverse
Shoulder Prosthesis System and is intended for use in total shoulder or hemi-shoulder replacement
procedures in patients with non-functional rotator cuffs.
Diameter (mm) 8-14
Size Standard or Long Length
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:56:42 AEDT
This is not an ARTG Certificate document.
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