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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 the device name listed in this FDA 510(k) record. The listed applicant is Eminent Spine, LLC. It received FDA 510(k) clearance on 2024-06-04 under 510(k) 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. The listed applicant is Eminent Spine, LLC. The 510(k) number is K240505.

When did Eminent Spine SI Screw System receive FDA 510(k) clearance?

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

Who is the listed applicant for Eminent Spine SI Screw System?

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

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

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

Other records listing Eminent Spine, 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.

K250894Eminent Spine Posterior SI SystemK241663Eminent Spine 3D Titanium Pedicle Screw SystemK242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemK230219Eminent Spine 3D Lumbar Interbody Fusion SystemsK212701Eminent Spine 3D Cervical Interbody Fusion SystemK221936Standalone ALIF Interbody Fusion 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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