|
Device | RAY TFC DEVICE AND 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 | S009 |
Date Received | 05/03/1999 |
Decision Date | 03/02/2000 |
Reclassified Date
|
07/12/2007 |
Product Code |
MAX |
Docket Number | 00M-1212 |
Advisory Committee |
Orthopedic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Modified indications for use for the Ray TFC and Unite Threaded Fusion Cage with instrumentation. These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (DDD) at one or two levels for L2 to S1. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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