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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral cervical device
Regulation Number888.3080
Applicant MEDTRONIC INC.
PMA NumberP000028
Supplement NumberS005
Date Received05/19/2004
Decision Date06/18/2004
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative surgical technique in which the reaming step is removed from the surgical procedure.
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