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 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 | S002 |
Date Received | 02/05/1997 |
Decision Date | 05/09/1997 |
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 OF THE ADDITION OF THE FOLLOWING SIZES TO THE BAK PRODUCT LINE: A) BAK IMPLANTS (MINOR DIAMETER (MM) X LENGTH (MM)) 11X20, 11X24, 11X28, 11X32, 11X36; 13X24, 13X28, 13X32, 13X36, 13X40; 15X28, 15X32, 15X36, 15X40, 15X44; 17X20, 17X32, 17X36, 17X40, 17X44; 19X24, 19X28, 19X32, 19X36, 19X40, 19X44; 21X28, 21X32, 21X36, 21X40, 21X44; AND (B) END CAPS (DIAMETER (MM)) 11; 19; AND 21. |
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