The following data is part of a premarket notification filed by Degen Medical with the FDA for Latitude-c Cervical Interbody Spacer System.
| Device ID | K151496 |
| 510k Number | K151496 |
| Device Name: | Latitude-C Cervical Interbody Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Degen Medical 1321-C North Cashua Drive Florence, SC 29501 |
| Contact | Craig Black |
| Correspondent | Linda Braddon SECURE BIOMED EVALUATIONS 7828 HICKORY FLAT HIGHWAY SUITE 120 Woodstock, GA 30188 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-03 |
| Decision Date | 2015-12-15 |
| Summary: | summary |