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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
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