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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 LITE BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantORTHOFIX, INC.
PMA NumberP850007
Supplement NumberS018
Date Received05/07/1996
Decision Date04/16/1997
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the design and labeling of the physio-stim(r) bone growth stimulator. The device, as modified, is to be marketed under the trade name physio-stim(r) lite and is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding bertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when a minimum of nine months has elapsed since injury and the fracture site shows no visibly progressive signs of helaing for a minimum of three months (no change in the fracture callus).
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