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FDA 510(k)

Eminent Spine SI Screw System

K-Number: K240505 · 2024-06-04

ApplicantEminent Spine, LLC
Decision Date2024-06-04
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Eminent Spine SI Screw System is a medical device manufactured by Eminent Spine, LLC. It received FDA 510(k) clearance on 2024-06-04 under approval number K240505. 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 SI Screw System?

Eminent Spine SI Screw System is a medical device that received FDA 510(k) clearance on 2024-06-04. It is manufactured by Eminent Spine, LLC. The 510(k) number is K240505.

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

Eminent Spine SI Screw System received FDA 510(k) clearance on 2024-06-04, under approval number K240505.

What company makes Eminent Spine SI Screw System?

Eminent Spine SI Screw System is manufactured by Eminent Spine, LLC.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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 NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07574632 A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis. NOT_YET_RECRUITING

Other Devices by Eminent Spine, LLC

K201979Cervical Plate System K212853Cervical Stand-Alone System K230219Eminent Spine 3D Lumbar Interbody Fusion Systems

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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