The following data is part of a premarket notification filed by Blustone Synergy, Llc with the FDA for Blustone Synergy Diamond Sa Cervical System.
| Device ID | K210382 |
| 510k Number | K210382 |
| Device Name: | Blustone Synergy Diamond SA Cervical System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Blustone Synergy, LLC 5520 Ventana Ct Pueblo, CO 81005 |
| Contact | Tom Gentry |
| Correspondent | Christine Scifert MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, CO 80112 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-09 |
| Decision Date | 2021-07-23 |