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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, lumbar
510(k) Number K191581
Device Name Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
Titan Spine, Inc
6140 W. Executive Dr., Suite A
Mequon,  WI  53092
Applicant Contact Kelly McDonnell
Mrc/x, Llc
6075 Poplar Avenue
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
Subsequent Product Code
Date Received06/14/2019
Decision Date 01/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No