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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.
 
Trade NamePHYSIO-STIM & SPINAL-STIM
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantORTHOFIX, INC.
PMA NumberP850007
Supplement NumberS028
Date Received05/13/2009
Decision Date07/10/2009
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the relocation and change of the charge management controller and the replacement of the charger unit. The device, as modified, will be marketed under the trade name physio-stim and spinal-stim. The physio-slim is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defects is less than one-half the width of the bone to be treated. A nonunion is considered lo be established when the fracture site shows no visibly progressive signs of healing. The spinal-slim 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 last surgery.
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