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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 (TM)1000 BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantDjo, LLC
1430 Decision St.
Vista, CA 92081
PMA NumberP910066
Supplement NumberS011
Date Received08/20/1998
Decision Date12/17/1999
Reclassified Date05/18/2026
Product Code LOF 
Docket Number 00M-1073
Advisory Committee Orthopedic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to the indications for use and will be marked under the tradename SpinaLogic.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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