The following data is part of a premarket notification filed by Life Spine with the FDA for Aileron Interspinous Fixation System.
| Device ID | K113157 |
| 510k Number | K113157 |
| Device Name: | AILERON INTERSPINOUS FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | LIFE SPINE 2401 Hassell Rd Ste 1535 Hoffman Est, IL 60169 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE 2401 Hassell Rd Ste 1535 Hoffman Est, IL 60169 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-26 |
| Decision Date | 2012-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837116248 | K113157 | 000 |