The following data is part of a premarket notification filed by Corelink, Llc with the FDA for F3d Corpectomy System.
| Device ID | K202637 |
| 510k Number | K202637 |
| Device Name: | F3D Corpectomy System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | CoreLink, LLC 2072 Fenton Logistics Park Blvd. St.louis, MO 63026 |
| Contact | Steven Mounts |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2020-12-23 |