K143158 is an FDA 510(k) clearance for the Xenco Medical Lumbar Interbody System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II - Special Controls, product code MAX).
Submitted by Xenco Medical, LLC (San Diego, US). The FDA issued a Cleared decision on March 20, 2015, 137 days after receiving the submission on November 3, 2014.
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 | K143158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2014 |
| Decision Date | March 20, 2015 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| 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. |