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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 K170611
Device Name SETx Pedicle Screw 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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWQ  
Date Received03/01/2017
Decision Date 05/25/2017
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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