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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 K192054
Device Name Endoskeleton TAS Plate
Applicant
Titan Spine, Inc
6140 W. Executive Dr., Suite A
Mequon,  WI  53092
Applicant Contact Kelly McDonnell
Correspondent
MRC/X, LLC
6075 Poplar Ave.
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
OVD  
Date Received07/31/2019
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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