The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Steerable Plateau Ti.
| Device ID | K193521 |
| 510k Number | K193521 |
| Device Name: | Steerable Plateau Ti |
| 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 | 2019-12-19 |
| Decision Date | 2020-02-06 |