The following data is part of a premarket notification filed by Sapphire Medical Group with the FDA for Matrix Ha Peek Cervical Implant System.
| Device ID | K192316 |
| 510k Number | K192316 |
| Device Name: | Matrix HA PEEK Cervical Implant System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Sapphire Medical Group 32565 B Golden Lantern Street, Suite 113 Dana Point, CA 92629 |
| Contact | Anthony Ruggiero |
| Correspondent | Marshall Mccarty Innovasis, Inc. 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 | 2019-08-26 |
| Decision Date | 2019-10-17 |