FDA 510(k)

OptumSI Implant System

K-Number: K251365 · 2025-11-20

Decision Date2025-11-20

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OptumSI Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Si Solutions, LLC. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K251365. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptumSI Implant System?

OptumSI Implant System is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Si Solutions, LLC. The 510(k) number is K251365.

When did OptumSI Implant System receive FDA 510(k) clearance?

OptumSI Implant System received FDA 510(k) clearance on 2025-11-20, under 510(k) number K251365.

Who is the listed applicant for OptumSI Implant System?

The FDA 510(k) record lists Si Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptumSI Implant System?

The FDA product code for OptumSI Implant System is OUR.

Related Devices (Code: OUR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web Medical K252322SIros-X SystemGenesys Spine K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.