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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 K120464
Device Name INNESIS PEEK CAGE
Applicant
BK MEDITECH CO., LTD.
8 east broadway, ste 611
salt lake city,  UT  84111
Contact shin kuk yoo
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/15/2012
Decision Date 01/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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