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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 K192018
Device Name Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic 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
Applicant
Titan Spine, Inc.
6140 W. Executive Dr., Suite A
Mequon,  WI  53092
Applicant Contact Jane Rodd
Correspondent
Titan Spine, Inc.
6140 W. Executive Dr., Suite A
Mequon,  WI  53092
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   OVD   OVE  
Date Received07/29/2019
Decision Date 08/16/2019
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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