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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 K152302
Device Name Xenco Medical Cervical Interbody System (Argus)
Applicant
Xenco Medical, LLC
9930 Mesa Rim Road
San Diego,  CA  92121
Applicant Contact Gustavo Prado
Correspondent
Xenco Medical, LLC
9930 Mesa Rim Road
San Diego,  CA  92121
Correspondent Contact Gustavo R Prado
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/14/2015
Decision Date 09/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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