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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, Cervical
510(k) Number K183557
Device Name Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
Applicant
Titan Spine, Inc.
6140 W. Executive Dr., Suite A
Mequon,  WI  53092
Applicant Contact Jane Rodd
Correspondent
Mrc/X, LLC
6075 Poplar Ave.
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   MQP   OVD   OVE  
Date Received12/20/2018
Decision Date 02/11/2019
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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