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 | K133947 |
| 510k Number | K133947 |
| Device Name: | IRIX-A LUMBAR INTEGRATED FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | X-SPINE SYSTEMS, INC 452 Alexandersville Rd Miamisburg, OH 45342 |
| Contact | David Kirschman |
| Correspondent | David Kirschman X-SPINE SYSTEMS, INC 452 Alexandersville 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 | 2013-12-23 |
| Decision Date | 2014-07-29 |
| Summary: | summary |