The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Arx Spinal System.
| Device ID | K200070 |
| 510k Number | K200070 |
| 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 |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837118471 | K200070 | 000 |
| 00190837094102 | K200070 | 000 |
| 00190837094119 | K200070 | 000 |
| 00190837094126 | K200070 | 000 |
| 00190837094133 | K200070 | 000 |
| 00190837031596 | K200070 | 000 |
| 00190837031602 | K200070 | 000 |
| 00190837031619 | K200070 | 000 |
| 00190837031626 | K200070 | 000 |
| 00190837031633 | K200070 | 000 |
| 00190837031640 | K200070 | 000 |
| 00190837205034 | K200070 | 000 |
| 00190837205041 | K200070 | 000 |
| 00190837094096 | K200070 | 000 |