510(k) K182920 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
MiRus 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)
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, Mar 13, 2019 |
| Received | Oct 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182920
No recall in the FDA data names this 510(k).
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