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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K113478
Device Name PLIF CAGE
Original Applicant
EISERTECH, LLC
2555 front street
san diego,  CA  92103
Original Contact lukas eisermann
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/23/2011
Decision Date 03/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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