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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Orthofix, Inc.
3451 plano parkway
lewisville, TX 75056
PMA NumberP850007
Supplement NumberS031
Date Received01/19/2011
Decision Date03/11/2011
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications to the garment covering, the treatment coils, liquid crystal display, control unit housing profile, orientation of the controls, software/ firmware, power supply cord, and labeling. The device, as modified, will be marketed under the trade name spinal-stim and is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a non-operative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.