Stimulator, bone growth, ultrasonic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Available from:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Class:

Class IIa

Manufactured by:

Bioventus LLC 4721 Emperor Boulevard Suite 100, Durham, NC, 27703 United States Of America

Therapeutic area:

18154 - Stimulator, bone growth, ultrasonic

Therapeutic indications:

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.

Authorization status:

A

Authorization date:

2014-02-28

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