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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, End
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
Recalls CDRH Recalls
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