Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM
• Generic Name: Stimulator, bone growth, non-invasive
• Regulation Number: 890.5870
• Applicant: Orthofix, Inc.; 3451 Plano Pkwy.; Lewisville, TX 75056
• PMA Number: P030034
• Date Received: 08/22/2003
• Decision Date: 12/23/2004
• Reclassified Date: 05/18/2026
• Product Code: LOF
• Docket Number: 05M-0028
• Notice Date: 01/21/2005
• Advisory Committee: Orthopedic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: 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 S009 S010 S011 ; S012 S013 S014 S015 S017