The following data is part of a premarket notification filed by Linkspine Inc with the FDA for Corticalink Spinal Fusion Platform.
| Device ID | K173484 |
| 510k Number | K173484 |
| Device Name: | CorticaLINK Spinal Fusion Platform |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | LinkSPINE Inc 5950 Symphony Woods Road, Suite 620 Columbia, MD 21044 |
| Contact | Nickolas Kriska |
| Correspondent | Nickolas G. Kriska LinkSPINE Inc 5950 Symphony Woods Road, Suite 620 Columbia, MD 21044 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2017-12-11 |
| Summary: | summary |