FDA.report

510(k) K251365

Device
OptumSI Implant System
Applicant
Si Solutions, LLC
510(k) number
K251365
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-20
Date received
2025-05-01
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
No

Related Records

Applicant Contact

Contact
Craig Meyer
Address
1010 Club Village Dr. Suite C Columbia MO US 62503 62503

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00850057247121OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247008OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247015OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247022OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247039OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247046OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247053OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247060OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247077OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247084OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247091OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247107OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247114OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247251OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247138OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247145OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247152OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247169OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247176OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247183OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247190OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247206OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247213OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247220OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247237OptumSI Implant SystemSI Solutions, LLC2025-12-16
00850057247244OptumSI Implant SystemSI Solutions, LLC2025-12-16

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
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
K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.2025-06-26
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