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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.
 
DeviceSPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantDjo, LLC
1430 Decision St.
Vista, CA 92081
PMA NumberP910066
Supplement NumberS025
Date Received06/12/2008
Decision Date12/24/2008
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR UPGRADES TO THE OL1000 SINGLE COIL, SIZE 1 MODEL AND THE MICROPROCESSOR-CONTROLLER (CONTROL BOX) USED FOR THE OL1000 SINGLE COIL, SIZE 1 MODEL.
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