The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Prolift Wedge Expandable Spacer System.
| Device ID | K203361 |
| 510k Number | K203361 |
| Device Name: | ProLift Wedge 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 | 2020-11-16 |
| Decision Date | 2021-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837107741 | K203361 | 000 |
| 00190837152628 | K203361 | 000 |
| 00190837152635 | K203361 | 000 |
| 00190837152642 | K203361 | 000 |
| 00190837152659 | K203361 | 000 |
| 00190837152666 | K203361 | 000 |
| 00190837152673 | K203361 | 000 |
| 00190837152680 | K203361 | 000 |
| 00190837152697 | K203361 | 000 |
| 00190837152611 | K203361 | 000 |
| 00190837152604 | K203361 | 000 |
| 00190837200060 | K203361 | 000 |
| 00190837145613 | K203361 | 000 |
| 00190837145620 | K203361 | 000 |
| 00190837145644 | K203361 | 000 |
| 00190837152567 | K203361 | 000 |
| 00190837152574 | K203361 | 000 |
| 00190837152581 | K203361 | 000 |
| 00190837152598 | K203361 | 000 |
| 00190837152703 | K203361 | 000 |
| 00190837154868 | K203361 | 000 |
| 00190837152314 | K203361 | 000 |
| 00190837152321 | K203361 | 000 |
| 00190837152338 | K203361 | 000 |
| 00190837152345 | K203361 | 000 |
| 00190837152352 | K203361 | 000 |
| 00190837152369 | K203361 | 000 |
| 00190837107758 | K203361 | 000 |
| 00190837107697 | K203361 | 000 |
| 00190837152307 | K203361 | 000 |
| 00190837107734 | K203361 | 000 |
| 00190837145668 | K203361 | 000 |
| 00190837152840 | K203361 | 000 |
| 00190837145651 | K203361 | 000 |
| 00190837140779 | K203361 | 000 |
| 00190837143046 | K203361 | 000 |
| 00190837107703 | K203361 | 000 |
| 00190837107710 | K203361 | 000 |
| 00190837107727 | K203361 | 000 |
| 00190837156077 | K203361 | 000 |