510(k) clearances

RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology

Xenix Medical · Orthopedic

K262193Substantially EquivalentTraditionalNKB
Open FDA's page for this record
Third party flag
N
City
Orlando
Advisory committee description
Orthopedic
Address 1
149 W. Michigan
Statement or summary
Summary
Product code
NKB
Zip code
32806
Applicant
Xenix Medical
Decision date
2026-09-14
Decision code
SESE
Country code
US
Device name
RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology
Advisory committee
OR
Contact
Tyler Holschlag
K number
K262193
State
FL
Date received
2026-06-29
Review advisory committee
OR
Postal code
32806
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Thoracolumbosacral Pedicle Screw System
Medical specialty description
Orthopedic
Regulation number
888.3070
Device class
2
Registration number
1000493591, 3009380063, 3007922509, 9617544, 2029275, 1000432246, 9611274, 3010057495, 3012447612, 2648623, 1835831, 3015443158, 3004635447, 3010123256, 3004638600, 3008285983, 1528646, 3031261833, 2032098, 3009998573, 3003387384, 3040335671, 3010866843, 1424434, 3004049923, 8020776, 3005819474, 9611827, 3006493760, 3043543260, 3009540749, 3006404071, 3011656326, 3009417901, 3015179588, 1056553, 3011795235, 3023138345, 3007345964, 3022159082 +375 more
FEI number
1000493591, 3009380063, 3001551180, 3007922509, 1000116116, 1000432246, 3010057495, 3012447612, 2648623, 3015443158, 3004635447, 3010123256, 3004638600, 3008285983, 3002807113, 3031261833, 1000136451, 3009998573, 3003387384, 3040335671, 3010866843, 3003110073, 3004049923, 3005819474, 1000115656, 3003112432, 3006493760, 3043543260, 3000215273, 3009540749, 3006404071, 3011656326, 3009417901, 3015179588, 3011795235, 5870, 3023138345, 3007345964, 3022159082, 3010440433 +375 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.