The following data is part of a premarket notification filed by Surgalign Spine Technologies with the FDA for Cortera Spinal Fixation System.
| Device ID | K221403 |
| 510k Number | K221403 |
| Device Name: | Cortera Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Surgalign Spine Technologies 520 Lake Cook Road Suite 315 Deerfield, IL 60015 |
| Contact | Jessica Jho |
| Correspondent | Jessica Jho Surgalign Spine Technologies 520 Lake Cook Road Suite 315 Deerfield, IL 60015 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-08-19 |