The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Corelink Foundation 3d Anterior Lumbar System.
| Device ID | K180556 |
| 510k Number | K180556 |
| Device Name: | Corelink Foundation 3D Anterior Lumbar System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Corelink, LLC 7911 Forsyth Blvd, Suite # 200 St. Louis, MO 63105 |
| Contact | Steven D. Mounts |
| Correspondent | Vikki M. O'connor Ambriel Associates, Inc. 411 Walnut St. Unit 9236 Green Cove Springs, FL 32043 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-07-27 |
| Summary: | summary |