|
Device | LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK) |
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 | S030 |
Date Received | 11/15/2004 |
Decision Date | 02/04/2005 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS. SPECIFICALLY, THESE DESIGN CHANGES INVOLVED THE INCORPORATION OF A ROUNDED PROFILE TO THE CLOSED END OF THE TAPERED CAGE COMPONENTS. THE MODIFIED TAPERED CAGE COMPONENTS CAN ONLY BE IMPLANTED VIA AN ANTERIOR OPEN SURGICAL APPROACH. |