The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Arx Illiac Spinal Screw System.
| Device ID | K203163 |
| 510k Number | K203163 |
| Device Name: | ARx Illiac Spinal Screw 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 | 2020-10-23 |
| Decision Date | 2020-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837132958 | K203163 | 000 |
| 00190837133078 | K203163 | 000 |
| 00190837134556 | K203163 | 000 |
| 00190837133719 | K203163 | 000 |
| 00190837132996 | K203163 | 000 |
| 00190837134594 | K203163 | 000 |
| 00190837134631 | K203163 | 000 |
| 00190837134679 | K203163 | 000 |
| 00190837134792 | K203163 | 000 |
| 00190837135430 | K203163 | 000 |
| 00190837135478 | K203163 | 000 |
| 00190837135553 | K203163 | 000 |
| 00190837135591 | K203163 | 000 |
| 00190837135638 | K203163 | 000 |
| 00190837132835 | K203163 | 000 |
| 00190837132873 | K203163 | 000 |
| 00190837132910 | K203163 | 000 |
| 00190837135393 | K203163 | 000 |