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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 K083714
Device Name ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)
Applicant
TITAN SPINE, LLC
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Applicant Contact RICHARD JANSEN
Correspondent
TITAN SPINE, LLC
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Correspondent Contact RICHARD JANSEN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/15/2008
Decision Date 04/15/2009
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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