The following data is part of a premarket notification filed by Eminent Spine, Llc with the FDA for Cervical Stand-alone System.
| Device ID | K212853 |
| 510k Number | K212853 |
| Device Name: | Cervical Stand-Alone System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Eminent Spine, LLC 2004 Ventura Drive, Suite 100 Plano, TX 75093 |
| Contact | Stephen Courtney |
| Correspondent | Meredith Lee May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2021-11-05 |