The following data is part of a premarket notification filed by Corelink Llc with the FDA for Foundation Interbody Devices.
| Device ID | K150847 |
| 510k Number | K150847 |
| Device Name: | Foundation Interbody Devices |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | CORELINK LLC 7606 FORSYTH BLVD Clayton, MO 63105 |
| Contact | Sharon Gregory |
| Correspondent | J.d. Webb THE ORTHOMEDIX GROUP, INC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-31 |
| Decision Date | 2015-08-13 |
| Summary: | summary |