The following data is part of a premarket notification filed by Life Spine, Inc with the FDA for Solstice Oct System.
| Device ID | K142253 |
| 510k Number | K142253 |
| Device Name: | SOLSTICE OCT System |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE, INC 13951 South Quality Drive Huntley, IL 60142 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-14 |
| Decision Date | 2015-04-23 |
| Summary: | summary |