510(k) K191906 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, May 18, 2020 |
| Received | Jul 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191906
No recall in the FDA data names this 510(k).
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