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 Lu

Intervertebral Fusion Device With Bone Graft, Lumbar

MiRus, LLC

The following data is part of a premarket notification filed by Mirus, Llc with the FDA for 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 Lu.

Pre-market Notification Details

• Device ID: K182920
• 510k Number: K182920
• Device Name: 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 Lu
• 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 SE, Suite 108 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: 2018-10-19
• Decision Date: 2019-03-13