The following data is part of a premarket notification filed by Life Spine, Inc with the FDA for Aileron Interspinous Fixation System.
| Device ID | K140236 |
| 510k Number | K140236 |
| Device Name: | AILERON INTERSPINOUS FIXATION SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates, IL 60169 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-30 |
| Decision Date | 2014-10-20 |
| Summary: | summary |