FDA 510(k) Applications Submitted by Jordan Baum
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K212784 |
09/01/2021 |
TightRail Guardian Motorized Dilator Sheath |
Spectranetics, Inc. |
| K223472 |
11/17/2022 |
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) |
Spectranetics Inc. |
| K220115 |
01/14/2022 |
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System |
MiRus, LLC |
| K180337 |
02/07/2018 |
EUROPA Pedicle Screw System |
MiRus, LLC |
| K230369 |
02/10/2023 |
EUROPAÖ Navigated Instruments |
MiRus LLC |
| K220441 |
02/16/2022 |
CYGNUSÖ MoRe Anterior Cervical Plate System |
MiRus, LLC |
| K190415 |
02/21/2019 |
ATLAS Plating System |
MiRus, LLC |
| K190618 |
03/11/2019 |
RIGEL PEEK Anterior Cervical Interbody Fusion System |
MiRus, LLC |
| K190666 |
03/15/2019 |
CYGNUSÖ Anterior Cervical Plate System |
MiRus, LLC |
| K200685 |
03/16/2020 |
RIGEL 3DR Anterior Cervical Interbody Fusion System |
MiRus, LLC |
| K210800 |
03/16/2021 |
IO Expandable Lumbar Interbody Fusion System |
MiRus, LLC |
| K191757 |
07/01/2019 |
EUROPA Pedicle Screw System |
MiRus, LLC |
| K191867 |
07/12/2019 |
ATLAS Plating System |
MiRus, LLC |
| K191906 |
07/16/2019 |
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 |
MiRus, LLC |
| K232154 |
07/20/2023 |
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation |
MiRus, LLC |
| K192268 |
08/21/2019 |
Europa Pedicle Screw System |
MiRus, LLC |
| K182524 |
09/13/2018 |
GALILEO Spine Alignment Monitoring System |
MiRus, LLC |
| K182920 |
10/19/2018 |
MiRusÖ Lumbar Interbody Fusion System consisting of CALLISTOÖ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERIONÖ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSOÖ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARESÖ PEEK Anterior Lumbar |
MiRus, LLC |
| K182970 |
10/26/2018 |
EUROPAÖ Pedicle Screw System |
MiRus, LLC |
| K182989 |
10/29/2018 |
AURORAÖ Screw System |
MiRus, LLC |
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