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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K160986
Device Name Xenco Medical Pedicle Screw System
Applicant
XENCO MEDICAL, LLC
9930 mesa rim drive
san diego,  CA  92121
Applicant Contact gustavo prado
Correspondent
XENCO MEDICAL, LLC
9930 mesa rim road
san diego,  CA  92121
Correspondent Contact gustavo prado
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received04/08/2016
Decision Date 05/04/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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