510(k) K182920
K182920 is an FDA 510(k) premarket notification submitted by MiRus, LLC for the 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)". The FDA issued a decision of Substantially Equivalent on Mar 13, 2019. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. MiRus, LLC has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 2019
- Date Received
- Oct 19, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.