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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 NumberS006
Date Received07/30/2004
Decision Date08/24/2004
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of sterilization validation methods for the affinity anterior cervical cage system.
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