The following data is part of a premarket notification filed by Mirus, Llc with the FDA for 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.
| Device ID | K191906 |
| 510k Number | K191906 |
| Device Name: | 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 |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MiRus, LLC 2150 Newmarket Parkway Marietta, GA 30067 |
| Contact | Jordan Bauman |
| Correspondent | Jordan Bauman MiRus, LLC 2150 Newmarket Parkway Marietta, GA 30067 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-16 |
| Decision Date | 2020-05-18 |