The following data is part of a premarket notification filed by Life Spine with the FDA for Solstice Cross Connector.
| Device ID | K120998 |
| 510k Number | K120998 |
| Device Name: | SOLSTICE CROSS CONNECTOR |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-10-01 |
| Summary: | summary |