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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B644KCP151100 | K203154 | 000 |
B644KCP14810 | K203154 | 000 |
B644KCP14840 | K203154 | 000 |
B644KCP14870 | K203154 | 000 |
B644KCP14900 | K203154 | 000 |
B644KCP150900 | K203154 | 000 |
B644KCP150950 | K203154 | 000 |
B644KCP151000 | K203154 | 000 |
B644KCP151050 | K203154 | 000 |
B644KCP14780 | K203154 | 000 |