The following data is part of a premarket notification filed by Axis Orthopaedics with the FDA for Axis Chena Cervical Peek Spacer System.
| Device ID | K181140 |
| 510k Number | K181140 |
| Device Name: | Axis Chena Cervical PEEK Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| 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 | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B644CCS1517515100 | K181140 | 000 |
| B644CCS1513511060 | K181140 | 000 |
| B644CCS1513511070 | K181140 | 000 |
| B644CCS1513511080 | K181140 | 000 |
| B644CCS1513511090 | K181140 | 000 |
| B644CCS1513511100 | K181140 | 000 |
| B644CCS1515513050 | K181140 | 000 |
| B644CCS1515513060 | K181140 | 000 |
| B644CCS1515513070 | K181140 | 000 |
| B644CCS1515513080 | K181140 | 000 |
| B644CCS1515513090 | K181140 | 000 |
| B644CCS1515513100 | K181140 | 000 |
| B644CCS1517515050 | K181140 | 000 |
| B644CCS1517515060 | K181140 | 000 |
| B644CCS1517515070 | K181140 | 000 |
| B644CCS1517515080 | K181140 | 000 |
| B644CCS1517515090 | K181140 | 000 |
| B644CCS1513511050 | K181140 | 000 |