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FDA 510(k)

Patriot SI Implant System

K-Number: K250001 · 2025-06-03

ApplicantSpinal Simplicity, LLC
Decision Date2025-06-03
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Patriot SI Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K250001. 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 Patriot SI Implant System?

Patriot SI Implant System is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K250001.

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

Patriot SI Implant System received FDA 510(k) clearance on 2025-06-03, under 510(k) number K250001.

Who is the listed applicant for Patriot SI Implant System?

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

What is the FDA product code for Patriot SI Implant System?

The FDA product code for Patriot SI Implant System is OUR.

Other records listing Spinal Simplicity, LLC as applicant

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.

K253523Freedom DS™ Decompression SystemK253250Minuteman® G6 MIS Fusion PlateK240592Wolff's Law Anterior Cervical Plate SystemK232259Patriot-SI Posterior Implant SystemK234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3K231923Liberty SI Lateral Implant System

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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 MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

Official Source

View on FDA Database →

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

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