|
Device | CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | Orthofix, Inc. 3451 Plano Parkway Lewisville, TX 75056 |
PMA Number | P030034 |
Date Received | 08/22/2003 |
Decision Date | 12/23/2004 |
Product Code |
LOF |
Docket Number | 05M-0028 |
Notice Date | 01/21/2005 |
Advisory Committee |
Orthopedic |
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 S009 S010 S011 S012 S013 S014 S015 S017 |