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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 K153122
Device Name Endoskeleton(r) TCS System
Applicant
TITAN SPINE, LLC
6140 W. EXECUTIVE DRIVE, SUITE A
MEQUON,  WI  53092
Applicant Contact Jane Rodd
Correspondent
Memphis Regulatory Consulting, LLC
3416 Roxee Run Cove
Bartlett,  TN  38133
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received10/29/2015
Decision Date 12/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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