K232154 is an FDA 510(k) clearance for the MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II - Special Controls, product code OVD).
Submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on September 11, 2023, 53 days after receiving the submission on July 20, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation..
| 510(k) Number | K232154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2023 |
| Decision Date | September 11, 2023 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation. |