The following data is part of a premarket notification filed by Kahtnu Surgical, Inc with the FDA for Kasilof Cervical Plate System.
| Device ID | K203154 |
| 510k Number | K203154 |
| Device Name: | KASILOF Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Kahtnu Surgical, Inc 170 E. Corral Ave. Suite 1 Soldotna, AK 99669 |
| Contact | Craig Wilcox |
| Correspondent | Ann Dunahoo MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-22 |
| Decision Date | 2020-11-05 |