Medical Device Manufacturer · US , Marietta , GA

MiRus, LLC

23 submissions · 23 cleared · Since 2018
23
Total
23
Cleared
0
Denied

MiRus, LLC — FDA 510(k) Submissions

MiRus, LLC has submitted 23 FDA 510(k) premarket notifications since 2018, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Bone Graft, Lumbar, Appliance, Fixation, Spinal Intervertebral Body, Orthopedic Stereotaxic Instrument, Plate, Fixation, Bone . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
ATLAS? Expandable Osteotomy Wedge System
K252733 · PLF Bone Wedge · Orthopedic
Feb 2026 175d
EUROPA? Posterior Cervical Fusion System
K242516 · NKG Posterior Cervical Screw... · Orthopedic
Nov 2024 88d
MiRus MoRe Lumbar Plating System
K241175 · KWQ Appliance, Fixation,... · Orthopedic
May 2024 21d
RIGEL? 3DR Standalone Anterior Cervical Interbody Fusion System
K232348 · OVE Intervertebral Fusion... · Orthopedic
Oct 2023 81d
RIGEL? 3DR Anterior Cervical Corpectomy System
K232481 · PLR Spinal Vertebral Body... · Orthopedic
Oct 2023 58d
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
K232154 · OVD Intervertebral Fusion... · Orthopedic
Sep 2023 53d
EUROPA? Navigated Instruments
K230369 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2023 133d
CYGNUS? MoRe Anterior Cervical Plate System
K220441 · KWQ Appliance, Fixation,... · Orthopedic
Sep 2022 212d
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
K220115 · OVD Intervertebral Fusion... · Orthopedic
May 2022 119d
IO Expandable Lumbar Interbody Fusion System
K210800 · MAX Intervertebral Fusion... · Orthopedic
Aug 2021 157d
RIGEL 3DR Anterior Cervical Interbody Fusion System
K200685 · ODP Intervertebral Fusion... · Orthopedic
Jun 2020 87d
MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
K191906 · MAX Intervertebral Fusion... · Orthopedic
May 2020 307d
ATLAS Plating System
K191867 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2020 272d
Europa Pedicle Screw System
K192268 · NKB Thoracolumbosacral... · Orthopedic
Oct 2019 62d
EUROPA Pedicle Screw System
K191757 · NKB Thoracolumbosacral... · Orthopedic
Jul 2019 18d
GALILEO Spine Alignment Monitoring System
K182524 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2019 277d
RIGEL PEEK Anterior Cervical Interbody Fusion System
K190618 · ODP Intervertebral Fusion... · Orthopedic
Jun 2019 87d
CYGNUS? Anterior Cervical Plate System
K190666 · KWQ Appliance, Fixation,... · Orthopedic
May 2019 55d
ATLAS Plating System
K190415 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2019 57d
EUROPA Pedicle Screw System
K180337 · NKB Thoracolumbosacral... · Orthopedic
Mar 2019 400d
MiRus? Lumbar Interbody Fusion System consisting of CALLISTO? PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION? PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO? PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES? PEEK Anterior Lumbar Interbody Fusion (ALIF)
K182920 · MAX Intervertebral Fusion... · Orthopedic
Mar 2019 145d
EUROPA? Pedicle Screw System
K182970 · NKB Thoracolumbosacral... · Orthopedic
Jan 2019 88d
AURORA? Screw System
K182989 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2018 50d
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