The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for The Solstice Oct System.
| Device ID | K170804 |
| 510k Number | K170804 |
| Device Name: | The Solstice OCT System |
| Classification | Posterior Cervical Screw System |
| 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 | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837069056 | K170804 | 000 |
| 00190837031428 | K170804 | 000 |
| 00190837031411 | K170804 | 000 |
| 00190837077433 | K170804 | 000 |
| 00190837077426 | K170804 | 000 |
| 00190837077419 | K170804 | 000 |
| 00190837077402 | K170804 | 000 |
| 00190837031725 | K170804 | 000 |
| 00190837031718 | K170804 | 000 |
| 00190837031701 | K170804 | 000 |
| 00190837031688 | K170804 | 000 |
| 00190837031671 | K170804 | 000 |
| 00190837031664 | K170804 | 000 |
| 00190837031657 | K170804 | 000 |
| 00190837031435 | K170804 | 000 |
| 00190837031442 | K170804 | 000 |
| 00190837069049 | K170804 | 000 |
| 00190837069032 | K170804 | 000 |
| 00190837069025 | K170804 | 000 |
| 00190837069018 | K170804 | 000 |
| 00190837069001 | K170804 | 000 |
| 00190837068998 | K170804 | 000 |
| 00190837068981 | K170804 | 000 |
| 00190837068974 | K170804 | 000 |
| 00190837068967 | K170804 | 000 |
| 00190837068950 | K170804 | 000 |
| 00190837068943 | K170804 | 000 |
| 00190837031466 | K170804 | 000 |
| 00190837031459 | K170804 | 000 |
| 00190837142315 | K170804 | 000 |