The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Monet Anterior Cervical Interbody Fusion Cage System With Supplementary Fixation Plate.
| Device ID | K182151 |
| 510k Number | K182151 |
| Device Name: | MONET Anterior Cervical Interbody Fusion Cage System With Supplementary Fixation Plate |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | CTL Medical Corporation 4550 Excel Parkway, Suite 300 Addison, TX 75001 |
| Contact | Andrea Wilcox |
| Correspondent | Barry E. Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-08 |
| Decision Date | 2018-10-11 |
| Summary: | summary |