The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Axle Interspinous Fusion System.
| Device ID | K130438 |
| 510k Number | K130438 |
| Device Name: | AXLE INTERSPINOUS FUSION SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg, OH 45342 |
| Contact | David Kirschman, M.d. |
| Correspondent | David Kirschman, M.d. X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg, OH 45342 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2013-06-27 |
| Summary: | summary |