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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732121058 | K162682 | 000 |
| 00841732120808 | K162682 | 000 |
| 00841732120792 | K162682 | 000 |
| 00841732120785 | K162682 | 000 |
| 00841732120778 | K162682 | 000 |
| 00841732120761 | K162682 | 000 |
| 00841732120754 | K162682 | 000 |
| 00841732120747 | K162682 | 000 |
| 00841732120730 | K162682 | 000 |
| 00841732120723 | K162682 | 000 |
| 00841732120716 | K162682 | 000 |
| 00841732120815 | K162682 | 000 |
| 00841732120822 | K162682 | 000 |
| 00841732121041 | K162682 | 000 |
| 00841732121034 | K162682 | 000 |
| 00841732121027 | K162682 | 000 |
| 00841732121010 | K162682 | 000 |
| 00841732121003 | K162682 | 000 |
| 00841732120877 | K162682 | 000 |
| 00841732120860 | K162682 | 000 |
| 00841732120853 | K162682 | 000 |
| 00841732120846 | K162682 | 000 |
| 00841732120839 | K162682 | 000 |
| 00841732120709 | K162682 | 000 |