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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 1000 BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namespinalogic 1000 bone growth stimulator
ApplicantDJ ORTHOPEDICS, LLC
PMA NumberP910066
Supplement NumberS021
Date Received06/10/2005
Decision Date07/19/2005
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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