|Trade Name||ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR|
|Classification Name||stimulator, bone growth, non-invasive|
|Generic Name||stimulator, bone growth, non-invasive|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a labeling change for the device to reference the results of an expanded patient data registry for patients treated with the device during the first two years of marketing for the approved indication.