The following data is part of a premarket notification filed by Corelink, Llc with the FDA for F3d-c2 Cervical Stand-alone System.
| Device ID | K211417 |
| 510k Number | K211417 |
| Device Name: | F3D-C2 Cervical Stand-Alone System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | CoreLink, LLC 2072 Fenton Logistics Blvd. St. Louis, MO 63026 |
| Contact | Steven Mounts |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-07 |
| Decision Date | 2022-02-04 |