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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 NameBAK INTERBODY FUSION SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namelumbar interbody fusion instrumentation
Regulation Number888.3080
ApplicantSPINTECH, INC.
PMA NumberP950002
Supplement NumberS001
Date Received12/26/1996
Decision Date07/22/1997
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to include the laparoscopic surgical approach in the labeling for the bak interbody fusion system.
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