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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 K121246
Device Name MEDYSSY LT CAGE SYSTEM
Original Applicant
MEDYSSEY CO., LTD.
8001 n. lincoln ave
skokie,  IL  60077
Original Contact michael kvitnisky
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/25/2012
Decision Date 06/15/2012
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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