The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Prolift Micro Expandable Spacer System.
| Device ID | K212520 |
| 510k Number | K212520 |
| Device Name: | ProLift Micro 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 | 2021-08-10 |
| Decision Date | 2021-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837141684 | K212520 | 000 |
| 00190837141707 | K212520 | 000 |
| 00190837141660 | K212520 | 000 |
| 00190837141721 | K212520 | 000 |