The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Arx Spinal System.
| Device ID | K191575 |
| 510k Number | K191575 |
| Device Name: | ARx Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-08-08 |