The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Rigel Peek Anterior Cervical Interbody Fusion System.
| Device ID | K190618 |
| 510k Number | K190618 |
| Device Name: | RIGEL PEEK Anterior Cervical Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MiRus, LLC 2150 Newmarket Parkway Marietta, GA 30067 |
| Contact | Jordan Bauman |
| Correspondent | Jordan Bauman MiRus, LLC 2150 Newmarket Parkway Marietta, GA 30067 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-11 |
| Decision Date | 2019-06-06 |