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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 K112986
Device Name LATERAL FUSION DEVICE
Original Applicant
INTEGRA SPINE (INTEGRA LIFESCIENCES)
1153 medina road
medina,  OH  44256
Original Contact dale davison
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/06/2011
Decision Date 05/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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