The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Arx® Spinal System.
| Device ID | K220025 |
| 510k Number | K220025 |
| 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 | 2022-01-05 |
| Decision Date | 2022-03-31 |