FDA.report

510(k) K251395

Device
The Rialto™ SI Fusion System
Applicant
Medtronic Sofamor Danek USA, Inc.
510(k) number
K251395
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-26
Date received
2025-05-05
Regulation
888.3040
Classification name
Sacroiliac Joint Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Rong Guo
Address
1800 Pyramid Pl. Memphis TN US 38132 38132

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OUR

510(k)DeviceApplicantDecision date
K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical2026-04-08
K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.2026-02-11
K253611Falco Fusion SystemMcnicoll Surgical, Inc.2026-01-29
K252834Sacroiliac Joint Truss System (SJTS)4Web Medical2026-01-28
K251365OptumSI Implant SystemSi Solutions, LLC2025-11-20
K252322SIros-X SystemGenesys Spine2025-10-22
K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.2025-10-09
K250894Eminent Spine Posterior SI SystemEminent Spine2025-10-07
K250647SImmetry+ SystemSivantage2025-07-29
K250247panaSIa SI Fusion SystemWenzel Spine, Inc.2025-07-09
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC2025-06-06
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC2025-06-06
K250001Patriot SI Implant SystemSpinal Simplicity, LLC2025-06-03
K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC2025-04-25
K250403Catamaran SI Joint Fusion SystemTenon Medical2025-03-21