The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Monet Anterior Cervical Plate System.
| Device ID | K220334 |
| 510k Number | K220334 |
| Device Name: | MONET Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CTL Medical Corporation 4550 Excel Pkwy Ste 300 Addison, TX 75001 |
| Contact | Sean Suh |
| Correspondent | Dhaval Saraiya Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington, DC 20003 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-04 |
| Decision Date | 2022-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732125193 | K220334 | 000 |
| 00841732125186 | K220334 | 000 |