The following data is part of a premarket notification filed by Life Spine with the FDA for Modification To:pilot Spinal System.
| Device ID | K080502 |
| 510k Number | K080502 |
| Device Name: | MODIFICATION TO:PILOT SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Rebecca M Brooks |
| Correspondent | Rebecca M Brooks LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-04-08 |
| Summary: | summary |