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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 NameMODEL SPF-60 SPINAL FUSION STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namesdpf implantable spinal fusion stimulator
ApplicantEBI, L.P.
PMA NumberP850035
Supplement NumberS029
Date Received06/13/2002
Decision Date12/06/2002
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model spf-60 implantable spinal fusion stimulator and is indicated for use as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
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