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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(R) MODEL 8212C
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantORTHOFIX, INC.
PMA NumberP850007
Supplement NumberS017
Date Received06/16/1995
Decision Date01/09/1997
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 model 8000c control unit which is to be used in conjunction with the existing model 212 treatment transducers, and for minor modifications to the labeling of the physician manual regarding patient compliance data retrieval and erasure. The device will be marketed under the trade name spinal-stim(r) and is indicated as a surgical adjunct for spinal fusion or as a nonoperative treatment where at least nine months have elapsed since the last surgery.
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