Device Listing 1468353834

Listing Summary#

Listing key
1468353834
Premarket submission
K182920
Device
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
Product code
MAX
Decision date
2019-03-13