FDA 510(k)

Duo Lumbar Interbody Fusion Device

K-Number: K190055 · 2019-03-07

Decision Date2019-03-07

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Duo Lumbar Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K190055. 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 Duo Lumbar Interbody Fusion Device?

Duo Lumbar Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Spineology, Inc.. The 510(k) number is K190055.

When did Duo Lumbar Interbody Fusion Device receive FDA 510(k) clearance?

Duo Lumbar Interbody Fusion Device received FDA 510(k) clearance on 2019-03-07, under 510(k) number K190055.

Who is the listed applicant for Duo Lumbar Interbody Fusion Device?

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

What is the FDA product code for Duo Lumbar Interbody Fusion Device?

The FDA product code for Duo Lumbar Interbody Fusion Device 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.

NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING NCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITING

Other records listing Spineology, Inc. as applicant

K251302OptiMesh Multiplanar Expandable Interbody Fusion System K251943Spineology Navigation Instruments K230927OptiMesh Multiplanar Expandable Interbody Fusion System K231781OptiMesh Multiplanar Expandable Interbody Fusion System K213876Spineology Navigation Instruments K210155Duo Expandable 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.