Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014655115

FEI Number

3014655115

Entity Name

MIRUS, LLC

City/State/Country

Marietta, GA, US

Establishment Address

1755 W Oak Parkway, Suite 100, Marietta, GA 30062, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MiRus, LLC (Owner Number: 10059692)

Owner / Operator Contact Address

1755 West Oak Parkway, Suite 100, Marietta, GA 30062, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190666

PMA Number

N/A

All Registered Proprietary Names

IO Expandable Osteotomy Wedge System CALLISTO 3DR PLIF HYPERION 3DR TLIF ANTARES 3DR ALIF CALYPSO 3DR LLIF EUROPA Pedicle Screw System IO Expandable Lumbar Interbody RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System MiRus MoRe Lumbar Plating System ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System EUROPA Posterior Cervical Fusion Navigated Instruments EUROPA Navigated Instruments Cygnus MoRe Anterior Cervical Plate System EUROPA Pedicle Screw System EUROPA Posterior Cervical Fusion System MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation CALYPSO PEEK LLIF CALLISTO PEEK PLIF HYPERION PEEK TLIF ANTARES PEEK ALIF RIGEL 3DR Cervical Interbody System RIGEL 3DR Anterior Cervical Corpectomy System EUROPA Pedicle Screw System Cygnus Anterior Cervical Plate System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2026-03-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-03-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-03-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-10-18
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-11-25
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-11-25
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-08-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-03-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-11-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-02-12
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2024-12-02
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-11-25
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-11-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-03-25
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-03-25
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2024-11-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2021-03-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2021-03-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-03-25
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-03-25

Official Correspondent

Jordan Bauman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MiRus, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K252254	Sinaptic Surgical	Osteotomy Wedge System	2025-10-17
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014655115. Last updated year: 2026. Please use registration number 3014655115 when referencing this establishment in official correspondence.