|
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 |
Supplement Number | S004 |
Date Received | 06/13/1997 |
Decision Date | 06/30/1997 |
Reclassified Date
|
07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF DESIGN CHANGES TO THE INSERTION END OF THE POLYETHYLENE ENDCAP AND THE INSERTION TOOLS USED AS PART OF THE BAK INTERBODY FUSION SYSTEM. |