The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Irix-c Cervical Integrated Fusion System.
| Device ID | K162944 |
| 510k Number | K162944 |
| Device Name: | Irix-C Cervical Integrated Fusion System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg, OH 45342 |
| Contact | Kriss Andersson |
| Correspondent | Kriss Andersson X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg, OH 45342 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-21 |
| Decision Date | 2016-11-07 |
| Summary: | summary |