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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 NameOL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantDJ ORTHOPEDICS, LLC
PMA NumberP910066
Supplement NumberS026
Date Received05/09/2012
Decision Date08/10/2012
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site and acceptance activities located in vista, california.
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