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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.
 
DeviceOSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP790005
Supplement NumberS039
Date Received10/17/1996
Decision Date07/17/1997
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model st-72 implant tester for use with the spf(r) implantable spinal fusion stimulator product line (spf(r) implantable spinal fusion stimulator product line (spf(r)-2t, spf(r)-4t, spf(r)-xl, and the spf(r)-xl ii) and the osteogen(tm) implantable spinal fusion stimulator product line.
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