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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, lumbar
510(k) Number K190364
Device Name CancelleX Porous Titanium Lumbar Interbody Device
Applicant
Xenco Medical, LLC
9930 Mesa Rim Road
San Diego,  CA  92121
Applicant Contact Jason Haider
Correspondent
KARA & Associates
6965 El Camino Real
Suite 105-428
Carlsbad,  CA  92009
Correspondent Contact Korina A. Akhondzadeh
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/15/2019
Decision Date 04/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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