Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Stimulator, bone growth, ultrasonic
ARTG entry for
Medical Device Included Class IIa
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class IIa
- 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.
4721 Emperor Boulevard Suite 100
Durham, NC, 27703
United States Of America
1. Stimulator, bone growth, ultrasonic
Single Device Product
18154 Stimulator, bone growth, ultrasonic
The Exogen SD (secure digital) Treatment Card is intended to be used with the Exogen Ultrasound Bone
Healing System which is indicated for the non-invasive treatment of osseous defects conservatively or
surgically treated (excluding vertebra and skull) that includes: Treatment of delayed unions and
non-unions; Accelerating the time to heal of fresh fractures; Treatment of stress fractures; Accelerating
repair following osteotomy; Accelerating repair of bone transport procedures; Accelerating repair in
distraction osteogenesis procedures; Treatment of joint fusion. The SD Treatment Card, when inserted in
the Exogen main operating unit, allows for a predetermined number of 20-minute treatments.
No Specific Conditions included on Record
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