FDA.reportPublic FDA data

510(k) K232154

Device
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
Applicant
MiRus, LLC
510(k) number
K232154
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-11
Date received
2023-07-20
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jordan Bauman
Address
1755 W. Oak Pkwy. Suite 100 Marietta GA US 30062 30062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261809Interwedge® Standalone LateralFoundation Surgical Group2026-07-31
K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.2026-07-15
K260810Anteralign LS coverplateTyber Medical, LLC2026-06-10
K254202MectaLIF 3D Metal AnteriorMedacta International S.A.2026-05-05
K253401SCRIPT™ Implant SystemGlobus Medical, Inc.2026-04-29
K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.2026-02-25
K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical2025-12-08
K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine2025-09-03
K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.2025-07-10
K251644ProAM ALIF SystemPro Surgical, Inc.2025-06-24
K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2025-06-18
K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC2025-06-12
K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC2025-04-30
K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC2025-04-22
K250603AxTiHA® Stand-Alone ALIF SystemInnovasis2025-03-24