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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 NameORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namespinalogic 1000 bone growth stimulator
ApplicantORTHOLOGIC CORP.
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 General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Change to the indications for use and will be marked under the tradename spinalogic.
Approval Order Approval Order
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