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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 integrated fixation, lumbar
510(K) Number K121211
Device Name VU APOD INTERVERTEBRAL BODY FUSION DEVICE
Applicant
THEKEN SPINE, LLC
1153 medina rd.
medina,  OH  44256
Contact dale davison
Regulation Number888.3080
Classification Product Code
OVD  
Date Received04/20/2012
Decision Date 06/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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