The following data is part of a premarket notification filed by Sapphire Medical Group with the FDA for Sapphire Cervical Implant System.
| Device ID | K172674 |
| 510k Number | K172674 |
| Device Name: | Sapphire Cervical Implant System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Sapphire Medical Group 32565 B Golden Lantern #113 Dana Point, CA 92629 |
| Contact | Anthony Ruggiero |
| Correspondent | Marshall Mccarty SpineWorks LLC 614 E. 3900 South Salt Lake City, UT 84107 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2017-11-02 |