The following data is part of a premarket notification filed by Axis Orthopaedics with the FDA for Axis Anterior Cervical Plate System.
| Device ID | K173867 |
| 510k Number | K173867 |
| Device Name: | Axis Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Axis Orthopaedics 34355 Poppy Wood St. Soldotna, AK 99669 |
| Contact | Craig Wilcox |
| Correspondent | Steve Brown CoorsTek Medical 560 W. Golf Course Rd Providence, UT 84332 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B644KCP11190 | K173867 | 000 |
| B644KCP12430 | K173867 | 000 |
| B644KCP12450 | K173867 | 000 |
| B644KCP12470 | K173867 | 000 |
| B644KCP12490 | K173867 | 000 |
| B644KCP12510 | K173867 | 000 |
| B644KCP12530 | K173867 | 000 |
| B644KCP12550 | K173867 | 000 |
| B644KCP13540 | K173867 | 000 |
| B644KCP13570 | K173867 | 000 |
| B644KCP13600 | K173867 | 000 |
| B644KCP12410 | K173867 | 000 |
| B644KCP12390 | K173867 | 000 |
| B644KCP11210 | K173867 | 000 |
| B644KCP11230 | K173867 | 000 |
| B644KCP11250 | K173867 | 000 |
| B644KCP11270 | K173867 | 000 |
| B644KCP11290 | K173867 | 000 |
| B644KCP11310 | K173867 | 000 |
| B644KCP11330 | K173867 | 000 |
| B644KCP11350 | K173867 | 000 |
| B644KCP12350 | K173867 | 000 |
| B644KCP12370 | K173867 | 000 |
| B644KCP13630 | K173867 | 000 |
| B644KCP13660 | K173867 | 000 |
| B644KCP13690 | K173867 | 000 |
| B644KCP15400180 | K173867 | 000 |
| B644KCP15401100 | K173867 | 000 |
| B644KCP15401120 | K173867 | 000 |
| B644KCP15401140 | K173867 | 000 |
| B644KCP15401160 | K173867 | 000 |
| B644KCP15401180 | K173867 | 000 |
| B644KCP15451100 | K173867 | 000 |
| B644KCP15451120 | K173867 | 000 |
| B644KCP15451140 | K173867 | 000 |
| B644KCP15451160 | K173867 | 000 |
| B644KCP15400160 | K173867 | 000 |
| B644KCP15400140 | K173867 | 000 |
| B644KCP13720 | K173867 | 000 |
| B644KCP13750 | K173867 | 000 |
| B644KCP13780 | K173867 | 000 |
| B644KCP14400100 | K173867 | 000 |
| B644KCP14400120 | K173867 | 000 |
| B644KCP14400140 | K173867 | 000 |
| B644KCP14400160 | K173867 | 000 |
| B644KCP14400180 | K173867 | 000 |
| B644KCP15400100 | K173867 | 000 |
| B644KCP15400120 | K173867 | 000 |
| B644KCP15451180 | K173867 | 000 |