|
Device | BAK INTERBODY FUSION SYSTEM |
Generic Name | Intervertebral fusion device with bone graft, lumbar |
Regulation Number | 888.3080 |
Applicant | Zimmer Spine, Inc 7375 Bush Lake Road Minneapolis, MN 55439 |
PMA Number | P950002 |
Date Received | 01/17/1995 |
Decision Date | 09/20/1996 |
Reclassified Date
|
07/12/2007 |
Product Code |
MAX |
Docket Number | 96M-0424 |
Notice Date | 11/18/1996 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE BAK INTERBODY FUSION SYSTEM WITH INSTRUMENTATION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 S013 S014 |