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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 K111626
Device Name ENDOSKELETON(R) TAS
Applicant
TITAN SPINE, LLC
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Applicant Contact RICH JANSEN
Correspondent
TITAN SPINE, LLC
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Correspondent Contact RICH JANSEN
Regulation Number888.3080
Classification Product Code
OVD  
Date Received06/10/2011
Decision Date 09/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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