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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, Cervical
510(k) Number K160313
Device Name Xenco Medical Cervical Interbody System
Applicant
Xenco Medical, LLC
9930 Mesa Rim Rd.
San Diego,  CA  92121
Applicant Contact GUSTAVO PRADO
Correspondent
Xenco Medical, LLC
9930 Mesa Rim Rd.
San Diego,  CA  92121
Correspondent Contact GUSTAVO PRADO
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received02/05/2016
Decision Date 10/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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