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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 1000 BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
ApplicantDJO, LLC
1430 DECISION STREET
VISTA, CA 92081-8553
PMA NumberP910066
Supplement NumberS021
Date Received06/01/2005
Decision Date07/19/2005
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  
APPROVAL FOR THE DESCRIBED COIL MODIFICATIONS INCLUDING GEOMETRIC CHANGES, TURN SCHEDULE CHANGES, AND MANUFACTURING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC 1000 BONE GROWTH STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
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