K182195 is an FDA 510(k) clearance for the Arco™-SA Lumbar Cage System. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II - Special Controls, product code OVD).
Submitted by Neurostructures, Inc. (Irvine, US). The FDA issued a Cleared decision on November 9, 2018, 87 days after receiving the submission on August 14, 2018.
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 | K182195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2018 |
| Decision Date | November 09, 2018 |
| Days to Decision | 87 days |
| Submission Type | Special |
| 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. |