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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.
 
DeviceORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
DJO, LLC
1430 decision street
vista, CA 92081-8553
PMA NumberP910066
Supplement NumberS011
Date Received08/20/1998
Decision Date12/17/1999
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 00M-1073
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the indications for use and will be marked under the tradename spinalogic.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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