The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Life Spine Lumbar Fixation System (sentry).
| Device ID | K180166 |
| 510k Number | K180166 |
| Device Name: | Life Spine Lumbar Fixation System (SENTRY) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Life Spine, Inc. 13951 S Quality Drive Huntley, IL 60142 |
| Contact | Randy Lewis |
| Correspondent | Angela Batker Life Spine, Inc. 13951 S Quality Drive Huntley, IL 60142 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-06-22 |
| Summary: | summary |