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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.
 
DeviceINTER FIX THREADED FUSION DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
Applicant
SOFAMOR DANEK
1800 pyramid place
memphis, TN 38132
PMA NumberP970015
Supplement NumberS028
Date Received07/01/2004
Decision Date07/19/2004
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of sterilization validation methods for the inter fix threaded fusion device.
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