Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | RAY THREADED FUSION CAGE(TFC) |
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 | S010 |
Date Received | 09/27/1999 |
Decision Date | 12/01/1999 |
Reclassified Date
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07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Sulzer Spine-Tech facility located at 8990 Springbrook Drive, #10, Minneapolis, Minnesota 55433 as an alternate site for assembly, packaging and quality control of the device and the BioTest Laboratories, Inc., located at 7375 Bush Lake Rd., Minneapolis, Minnesota 55439 as an alternate site for assembly, packaging and labeling of the device. |
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