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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.
 
DeviceBAK INTERBODY FUSION SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
Applicant
Zimmer Spine, Inc
7375 bush lake road
minneapolis, MN 55439
PMA NumberP950002
Supplement NumberS002
Date Received02/05/1997
Decision Date05/09/1997
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 of the addition of the following sizes to the bak product line: a) bak implants (minor diameter (mm) x length (mm)) 11x20, 11x24, 11x28, 11x32, 11x36; 13x24, 13x28, 13x32, 13x36, 13x40; 15x28, 15x32, 15x36, 15x40, 15x44; 17x20, 17x32, 17x36, 17x40, 17x44; 19x24, 19x28, 19x32, 19x36, 19x40, 19x44; 21x28, 21x32, 21x36, 21x40, 21x44; and (b) end caps (diameter (mm)) 11; 19; and 21.
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