K152302 is an FDA 510(k) clearance for the Xenco Medical Cervical Interbody System (Argus). This device is classified as a Intervertebral Fusion Device With Bone Graft, Cervical (Class II - Special Controls, product code ODP).
Submitted by Xenco Medical, LLC (San Diego, US). The FDA issued a Cleared decision on September 10, 2015, 27 days after receiving the submission on August 14, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K152302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2015 |
| Decision Date | September 10, 2015 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | ODP - Intervertebral Fusion Device With Bone Graft, Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |