The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Life Spine Laminoplasty System.
| Device ID | K181717 |
| 510k Number | K181717 |
| Device Name: | Life Spine Laminoplasty System |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| 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 | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-28 |
| Decision Date | 2018-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837085629 | K181717 | 000 |
| 00190837032081 | K181717 | 000 |