|
Device | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION |
Generic Name | Intervertebral fusion device with bone graft, lumbar |
Regulation Number | 888.3080 |
Applicant | STRYKER SPINE 2 Pearl Court Allendale, NJ 07401 |
PMA Number | P950019 |
Supplement Number | S007 |
Date Received | 02/18/1999 |
Decision Date | 03/19/1999 |
Reclassified Date
|
07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for modified device outer box labels. |