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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceORTHOLOGIC 1000 SC
Generic NameStimulator, bone growth, non-invasive
ApplicantDJO, LLC
1430 DECISION STREET
VISTA, CA 92081-8553
PMA NumberP910066
Supplement NumberS012
Date Received09/22/1998
Decision Date10/16/1998
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modifications to the sizes of the device. The device, as modified, will be marketed under the trade name Orthologic 1000-SC and is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
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