The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Ais-c Cervical Anchored Interbody System.
| Device ID | K180056 |
| 510k Number | K180056 |
| Device Name: | Genesys Spine AIS-C Cervical Anchored Interbody System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Genesys Spine 1250 Capital Of Texas Highway South Building 3 Suite 600 Austin, TX 78746 |
| Contact | Benjamin V. Keller |
| Correspondent | Benjamin V. Keller Genesys Spine 1250 Capital Of Texas Highway South Building 3 Suite 600 Austin, TX 78746 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-08 |
| Decision Date | 2018-03-28 |
| Summary: | summary |