The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc with the FDA for Polaris Spinal System.
| Device ID | K210275 |
| 510k Number | K210275 |
| Device Name: | Polaris Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Zimmer Biomet Spine, Inc 10225 Westmoor Drive Westminster, CO 80021 |
| Contact | Anjanet Mort |
| Correspondent | Anjanet Mort Zimmer Biomet Spine, Inc 10225 Westmoor Drive Westminster, CO 80021 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-04-02 |