The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Matisse Anterior Cervical Interbody Fusion Cage System.
| Device ID | K162682 |
| 510k Number | K162682 |
| Device Name: | MATISSE Anterior Cervical Interbody Fusion Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | CTL Medical Corporation 4550 Excel Parkway, Suite 300 Addison, TX 75001 |
| Contact | Tosan Onosode |
| Correspondent | Paul Speidel RQMIS Inc. 110 Haverhill Road Suite 526 Amesbury, MA 01913 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-06-01 |
| Summary: | summary |