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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 Namespinalogic 1000 bone growth stimulator
ApplicantDJ ORTHOPEDICS, LLC/REGENTEK
PMA NumberP910066
Supplement NumberS019
Date Received04/01/2004
Decision Date09/10/2004
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) change in the labeling to reflect the new company ownership from orthologic to dj orthopedics/ regentek; 2) addition of a product specifications section to all manuals to comply with canadian standards association. (applies to ol series and spinalogic manuals); 3) addition of reference section (applies to spinalogic manuals only); and 4) in risk and benefits section of the spinalogic patient manual, revision the statement "20% greater chance of back surgery healing" to "the benefit of the spinalogic is that you have a greater chance of your back surgery healing if you use the device every day than if you don not use it. ".
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