The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Irix-a Lumbar Integrated Fusion System.
| Device ID | K171567 |
| 510k Number | K171567 |
| Device Name: | IRIX-A Lumbar Integrated Fusion System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | X-Spine Systems, Inc. 452 Alexanderville Rd. Miamisburg, OH 45342 |
| Contact | Kriss Andersson |
| Correspondent | Charlene Brumbaugh X-Spine Systems, Inc. 452 Alexanderville Rd. Miamisburg, OH 45342 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2017-08-28 |
| Summary: | summary |