K162682 is an FDA 510(k) clearance for the MATISSE Anterior Cervical Interbody Fusion Cage System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Cervical (Class II - Special Controls, product code ODP).
Submitted by Ctl Medical Corporation (Addison, US). The FDA issued a Cleared decision on June 1, 2017, 248 days after receiving the submission on September 26, 2016.
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 | K162682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2016 |
| Decision Date | June 01, 2017 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| 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. |