FDA.report

MIRUS, LLC

Matched from indexed company URL: MiRus, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30146551153014655115MIRUS, LLC1N2026-01-011755 W Oak Parkway Suite 100 Marietta GA US 30062

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2271081804469234K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsOLO2026-03-18
2271081431792024K252733ATLAS™ Expandable Osteotomy Wedge SystemPLF2026-02-19
2271081414100090K242516EUROPA™ Posterior Cervical Fusion SystemNKG2024-11-19
2271081303021020K241175MiRus MoRe Lumbar Plating SystemKWQ2024-05-17
2271082003774950K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemPLR2023-10-13
2271081884462329K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemOVE2023-10-27
2271081767370914K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationOVD2023-09-11
2271081347036789K230369EUROPA™ Navigated InstrumentsOLO2023-06-23
2271081962849817K220441CYGNUS™ MoRe Anterior Cervical Plate SystemKWQ2022-09-16
2271081774640966K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemOVD2022-05-13
2271081330221184K210800IO Expandable Lumbar Interbody Fusion SystemMAX2021-08-20
2271081278666880K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemODP2020-06-11
2271082034143062K192268Europa Pedicle Screw SystemNKB2019-10-22
2271081575110218K191906MiRus 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 ALIFMAX2020-05-18
2271082017800170K191867ATLAS Plating SystemHRS2020-04-09
2271081365731684K191757EUROPA Pedicle Screw SystemNKB2019-07-19
2271081926208685K190666CYGNUS™ Anterior Cervical Plate SystemKWQ2019-05-09
2271082028924618K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemODP2019-06-06
2271081813520117K182970EUROPA™ Pedicle Screw SystemNKB2019-01-22
2271081813520117K182970EUROPA™ Pedicle Screw SystemNKB2019-01-22
2271081468353834K182920MiRus™ 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)MAX2019-03-13
2271081820496778K180337EUROPA Pedicle Screw SystemNKB2019-03-14
2271081472084928

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NKB52019-10-22
KWQ32024-05-17
MAX32021-08-20
OLO22026-03-18
OVD22023-09-11
ODP22020-06-11
PLF12026-02-19
NKG12024-11-19
OVE12023-10-27
PLR12023-10-13
HRS12020-04-09

PMN