The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Trulift Expandable Spacer System.
| Device ID | K201721 |
| 510k Number | K201721 |
| Device Name: | TruLift Expandable Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Life Spine Inc. 13951 S Quality Drive Huntley, IL 60142 |
| Contact | Angela Batker |
| Correspondent | Angela Batker Life Spine Inc. 13951 S Quality Drive Huntley, IL 60142 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2020-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837097271 | K201721 | 000 |
| 00190837097288 | K201721 | 000 |
| 00190837097318 | K201721 | 000 |
| 00190837097349 | K201721 | 000 |
| 00190837097332 | K201721 | 000 |
| 00190837097295 | K201721 | 000 |
| 00190837097325 | K201721 | 000 |
| 00190837097301 | K201721 | 000 |