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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, Cervical
510(k) Number K191565
Device Name Endoskeleton TCS Interbody Fusion Device
Applicant
Titan Spine, Inc
6140 W. Executive Dr., Suite A
Mequon,  WI  53092
Applicant Contact Kelly McDonnell
Correspondent
MRC/X, LLC
6075 Poplar Ave
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
OVE  
Date Received06/13/2019
Decision Date 08/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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