The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Prolift Expandable System.
| Device ID | K153400 |
| 510k Number | K153400 |
| Device Name: | ProLift Expandable System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-24 |
| Decision Date | 2016-03-07 |
| Summary: | summary |