The following data is part of a premarket notification filed by Spineway with the FDA for Ayers Rock Cervical Interbody Fusion System.
| Device ID | K162694 |
| 510k Number | K162694 |
| Device Name: | Ayers Rock Cervical Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Spineway 7 Allee Moulin Berger Ecully France 69130 Ecully, FR 69130 |
| Contact | Nicolas Roth |
| Correspondent | Tamala J. Wampler Novus Management Group, LLC. 6686 Dimmick Road West Chester, OH 45069 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-27 |
| Decision Date | 2017-01-12 |