The following data is part of a premarket notification filed by Life Spine, Inc with the FDA for Solstice Oct System.
| Device ID | K150229 |
| 510k Number | K150229 |
| Device Name: | SOLSTICE OCT System |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | LIFE SPINE, INC 13951 S Quality Drive Huntley, IL 60142 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE, INC 13951 S 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 | 2015-02-02 |
| Decision Date | 2015-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837008734 | K150229 | 000 |
| 00190837063429 | K150229 | 000 |
| 00190837063412 | K150229 | 000 |
| 00190837063405 | K150229 | 000 |
| 00190837063399 | K150229 | 000 |
| 00190837063382 | K150229 | 000 |
| 00190837063375 | K150229 | 000 |
| 00190837063368 | K150229 | 000 |
| 00190837063351 | K150229 | 000 |
| 00190837063436 | K150229 | 000 |
| 00190837063443 | K150229 | 000 |
| 00190837063450 | K150229 | 000 |
| 00190837008727 | K150229 | 000 |
| 00190837008710 | K150229 | 000 |
| 00190837008703 | K150229 | 000 |
| 00190837063504 | K150229 | 000 |
| 00190837063498 | K150229 | 000 |
| 00190837063481 | K150229 | 000 |
| 00190837063474 | K150229 | 000 |
| 00190837063467 | K150229 | 000 |
| 00190837063344 | K150229 | 000 |