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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 Namebone growth stimulator
ApplicantDJ ORTHOPEDICS, LLC
PMA NumberP910066
Supplement NumberS025
Date Received06/12/2008
Decision Date12/24/2008
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for upgrades to the ol1000 single coil, size 1 model and the microprocessor-controller (control box) used for the ol1000 single coil, size 1 model.
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