The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Prolift Lateral Helo Fixated.
| Device ID | K210061 |
| 510k Number | K210061 |
| Device Name: | ProLift Lateral HELO Fixated |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Life Spine, Inc. 139541 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 | 2021-01-11 |
| Decision Date | 2021-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837138462 | K210061 | 000 |