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 TFC UNITE PRODUCT LINE |
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 | S013 |
Date Received | 02/13/2003 |
Decision Date | 07/15/2003 |
Reclassified Date
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07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR NEW MANUFACTURING FACILITIES FOR THE RAY TFC UNITE PRODUCT LINE. THE FACILITIES ARE LOCATED AT CENTERPULSE SPINE-TECH, MINNEAPOLIS, MINNESOTA AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MINNESOTA. |
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