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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
Applicant Contact DALE DAVISON
Correspondent
THEKEN SPINE, LLC
1153 Medina Rd.
Medina,  OH  44256
Correspondent Contact DALE DAVISON
Regulation Number888.3080
Classification Product Code
OVD  
Date Received04/20/2012
Decision Date 06/27/2012
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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