The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Europa Pedicle Screw System.
| Device ID | K191757 |
| 510k Number | K191757 |
| Device Name: | EUROPA Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-07-19 |