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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 K140786
Device Name XENCO MEDICAL CERVICAL INTERBODY SYSTEM
Applicant
Xenco Medical, LLC
9930 Mesa Rim Dr.
San Diego,  CA  92121
Applicant Contact GUSTAVO R PRADO
Correspondent
Xenco Medical, LLC
9930 Mesa Rim Dr.
San Diego,  CA  92121
Correspondent Contact GUSTAVO R PRADO
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/31/2014
Decision Date 09/03/2014
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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