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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 K262193
Device Name RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology
Applicant
Xenix Medical
149 W. Michigan
Orlando,  FL  32806
Applicant Contact Tyler Holschlag
Correspondent
Xenix Medical
149 W. Michigan
Orlando,  FL  32806
Correspondent Contact Tyler Holschlag
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   OLO   OUR  
Date Received06/29/2026
Decision Date 09/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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