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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Orthofix, Inc.
3451 plano parkway
lewisville, TX 75056
PMA NumberP030034
Date Received08/22/2003
Decision Date12/23/2004
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 05M-0028
Notice Date 01/21/2005
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cervical-stim model 505l cervical fusion system. The cervical-stim model 505l cervical fusion system is a non-invasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007 S008