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FDA 510(k)

Eminent Spine Posterior SI System

K-Number: K250894 · 2025-10-07

ApplicantEminent Spine
Decision Date2025-10-07
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Eminent Spine Posterior SI System is a medical device manufactured by Eminent Spine. It received FDA 510(k) clearance on 2025-10-07 under approval number K250894. 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 Eminent Spine Posterior SI System?

Eminent Spine Posterior SI System is a medical device that received FDA 510(k) clearance on 2025-10-07. It is manufactured by Eminent Spine. The 510(k) number is K250894.

When was Eminent Spine Posterior SI System approved by the FDA?

Eminent Spine Posterior SI System received FDA 510(k) clearance on 2025-10-07, under approval number K250894.

What company makes Eminent Spine Posterior SI System?

Eminent Spine Posterior SI System is manufactured by Eminent Spine.

What is the FDA product code for Eminent Spine Posterior SI System?

The FDA product code for Eminent Spine Posterior SI System is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED

Other Devices by Eminent Spine

K221936Standalone ALIF Interbody Fusion System K212701Eminent Spine 3D Cervical Interbody Fusion System K242069Eminent Spine Scoliosis Deformity Pedicle Screw System K241663Eminent Spine 3D Titanium Pedicle Screw System

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

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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