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, Ti-peek™.
| Device ID | K172212 |
| 510k Number | K172212 |
| Device Name: | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ |
| 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 | 2017-07-24 |
| Decision Date | 2018-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732125100 | K172212 | 000 |
| 00841732125025 | K172212 | 000 |
| 00841732125032 | K172212 | 000 |
| 00841732125049 | K172212 | 000 |
| 00841732125056 | K172212 | 000 |
| 00841732125063 | K172212 | 000 |
| 00841732125070 | K172212 | 000 |
| 00841732125087 | K172212 | 000 |
| 00841732125094 | K172212 | 000 |
| 00841732125018 | K172212 | 000 |