FDA 510(k)

Eminent Spine 3D Lumbar Interbody Fusion Systems

K-Number: K230219 · 2023-05-16

Decision Date2023-05-16

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Eminent Spine 3D Lumbar Interbody Fusion Systems 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 2023-05-16 under 510(k) number K230219. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eminent Spine 3D Lumbar Interbody Fusion Systems?

Eminent Spine 3D Lumbar Interbody Fusion Systems is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Eminent Spine, LLC. The 510(k) number is K230219.

When did Eminent Spine 3D Lumbar Interbody Fusion Systems receive FDA 510(k) clearance?

Eminent Spine 3D Lumbar Interbody Fusion Systems received FDA 510(k) clearance on 2023-05-16, under 510(k) number K230219.

Who is the listed applicant for Eminent Spine 3D Lumbar Interbody Fusion Systems?

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 3D Lumbar Interbody Fusion Systems?

The FDA product code for Eminent Spine 3D Lumbar Interbody Fusion Systems is MAX.

Related Clinical Trials

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.

NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05037968MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral FusionRECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING

Other records listing Eminent Spine, LLC as applicant

K250894Eminent Spine Posterior SI System K241663Eminent Spine 3D Titanium Pedicle Screw System K242069Eminent Spine Scoliosis Deformity Pedicle Screw System K240505Eminent Spine SI Screw System K212701Eminent Spine 3D Cervical Interbody Fusion System K221936Standalone ALIF Interbody Fusion System

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Related Devices (Code: MAX)

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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.