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 |