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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, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantORTHOFIX, INC.
PMA NumberP850007
Supplement NumberS024
Date Received09/22/1998
Decision Date11/03/1998
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval t use a smaller gauge wire for the transducer coil, change from pvc to neoprene for the inside and outside covers of both front and rear transducer coils, and slightly reduce the thickness of the kydex material. 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 and as a nonoperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
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