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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 NameSPINAL-STIM LITE SPINAL FUSION SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantORTHOFIX, INC.
PMA NumberP850007
Supplement NumberS019
Date Received06/12/1996
Decision Date09/19/1997
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the spinal-stim(r) lite spinal fusion system, model 212l. The device will be marketed under the trade name spinal-stim(r) and is indicated as a spinal fusion adjunct to increase the probability of fusion success ans as a nonooperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
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