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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSPINAL-STIM(R) MODEL 8212C
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix, Inc.
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS017
Date Received06/16/1995
Decision Date01/09/1997
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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