Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - DeltaMotion Modular Sleeve - Ceramic femoral
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.
COUNTY CORK, ,
1. DeltaMotion Modular Sleeve - Ceramic femoral head prosthesis
Single Device Product
38156 Ceramic femoral head prosthesis
DeltaMotion Modular Sleeves are a range of Titanium alloy sleeves for use with DeltaMotion
Modular Heads and which connect the heads to a suitable femoral stem. The sleeves are provided in
a range of sizes/offsets to allow some variation of the femoral neck length.
The DeltaMotion Modular Sleeves, when used in combination with a DeltaMotion Modular Ceramic head
during total hip arthroplasty, is intended to provide increased patient mobility and reduce pain by replacing
the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and
support the components.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:44:23 AEDT
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