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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
Recalls CDRH Recalls
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