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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.
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
PMA NumberP850022
Supplement NumberS009
Date Received03/13/1997
Decision Date09/24/1999
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 00M-0901
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 
Approval for spinalpak bone growth stimulator. The device is indicated as a noninvasive bone growth stimulator for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
Approval Order Approval Order