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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
Classification Namestimulator, bone growth, non-invasive
Generic Namespinalogic 1000 bone growth stimulator
ApplicantDJ ORTHOPEDICS, LLC
PMA NumberP910066
Supplement NumberS023
Date Received02/05/2007
Decision Date06/28/2007
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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