The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Foundation 3d Interbody.
| Device ID | K162496 |
| 510k Number | K162496 |
| Device Name: | Foundation 3D Interbody |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | CoreLink, LLC 7911 Forsyth Blvd, Suite # 200 St. Louis, MO 63105 |
| Contact | Stephan Jones |
| Correspondent | Kenneth C. Maxwell Ii Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-07 |
| Decision Date | 2017-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7253CZ18 | K162496 | 000 |
| M7253CZ16 | K162496 | 000 |
| M7253CZ14 | K162496 | 000 |
| M7253CF18 | K162496 | 000 |
| M7253CF16 | K162496 | 000 |
| M7253CF14 | K162496 | 000 |