The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Corelink F3d™ Lateral System.
| Device ID | K183239 |
| 510k Number | K183239 |
| Device Name: | CoreLink F3D™ Lateral System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Corelink, LLC 2072 Fenton Logistics Blvd. St. Louis, MO 63026 |
| Contact | Steven Mounts |
| Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street Suite 1000 Washington, DC 20001 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2018-12-19 |
| Summary: | summary |