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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
ApplicantDJO, LLC
1430 DECISION STREET
VISTA, CA 92081-8553
PMA NumberP910066
Supplement NumberS023
Date Received02/05/2007
Decision Date06/28/2007
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 MODIFICATIONS TO THE CONTROL BOX FOR THE OL1000, OL1000 SINGLE COIL (SIZE 2/3/4), AND SPINALOGIC DEVICES INCLUDING ENLARGED LCD ICON GRAPHICS AND PROMPTS, 9 VOLT ALKALINE BATTERY POWER SOURCE, AND UPDATED DEVICE SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS. THE OL1000 AND OL1000 SC DEVICES ARE INTENDED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES. THE SPINALOGIC DEVICE IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
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