K182920 is an FDA 510(k) clearance for the 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). This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II - Special Controls, product code MAX).
Submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on March 13, 2019, 145 days after receiving the submission on October 19, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K182920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2018 |
| Decision Date | March 13, 2019 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAX — Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |