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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 NumberS026
Date Received02/01/2001
Decision Date03/09/2001
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at orthofix, inc. , mckinney, texas.