Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BAK/L 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 | S008 |
Date Received | 10/22/1999 |
Decision Date | 12/20/1999 |
Reclassified Date
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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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the additional sizes to the BAK product line. |
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