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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.
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
Zimmer Spine, Inc
7375 bush lake road
minneapolis, MN 55439
PMA NumberP950002
Supplement NumberS008
Date Received10/22/1999
Decision Date12/20/1999
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the additional sizes to the bak product line.