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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 K121116
Device Name PLATEAU SPACER SYSTEM
Original Applicant
LIFE SPINE
2401 hassell rd ste 1535
hoffman est,  IL  60169
Original Contact randy lewis
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/12/2012
Decision Date 05/08/2012
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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