The following data is part of a premarket notification filed by X-spine Systems, Inc with the FDA for Axle Peek Interspinous Fusion System.
| Device ID | K112592 |
| 510k Number | K112592 |
| Device Name: | AXLE PEEK INTERSPINOUS FUSION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2011-12-05 |
| Summary: | summary |