The following data is part of a premarket notification filed by Spine Smith Holdings, Llc with the FDA for Corticalink Spinal Fusion Platform.
| Device ID | K193465 |
| 510k Number | K193465 |
| Device Name: | CorticaLINK Spinal Fusion Platform |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Spine Smith Holdings, LLC 4719 South Congress Ave. Austin, TX 78745 |
| Contact | Nickolas G. Kriska |
| Correspondent | Nickolas G. Kriska Spine Smith Holdings, LLC 4719 South Congress Ave. Austin, TX 78745 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-01-10 |