|
Device | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE |
Generic Name | Intervertebral fusion device with bone graft, lumbar |
Regulation Number | 888.3080 |
Applicant | SOFAMOR DANEK 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P970015 |
Supplement Number | S026 |
Date Received | 03/19/2004 |
Decision Date | 04/16/2004 |
Reclassified Date
|
07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE ELIMINATION OF THE REAMING STEP IN THE SURGICAL IMPLANTATION PROCEDURES FOR THE LT CAGE PEEK LUMBAR TAPERED FUSION DEVICE, THE LT CAGE LUMBER TAPERED FUSION DEVICE, AND THE INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE. |