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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.
 
DeviceCERVICAL-STIM CERVICAL FUSION SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
Orthofix, Inc.
3451 plano parkway
lewisville, TX 75056
PMA NumberP030034
Supplement NumberS005
Date Received01/19/2011
Decision Date03/11/2011
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR DESIGN MODIFICATIONS TO THE GARMENT COVERING, THE TREATMENT COILS, LIQUID CRYSTAL DISPLAY, CONTROL UNIT HOUSING PROFILE, ORIENTATION OF THE CONTROLS, SOFTWARE/ FIRMWARE, POWER SUPPLY CORD, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERVICAL-STIM AND IS INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSHION.
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