|
Device | RAY TFC DEVICE/RAY TFC UNITE DEVICE |
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 | S012 |
Date Received | 02/11/2002 |
Decision Date | 04/02/2002 |
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 |
Approval Order Statement APPROVAL FOR ADDITIONAL INSTRUMENTS FOR THE ALIF-OPEN SURGICAL TECHNIQUE FOR THE RAY TFC AND RAY TFC UNITE DEVICES AND REVISED LABELING. |