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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 BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantORTHOFIX, INC.
PMA NumberP850007
Supplement NumberS022
Date Received06/24/1998
Decision Date08/13/1998
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the definition of non-union in the labeling (i. E. , a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).
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