The following data is part of a premarket notification filed by Fusion Robotics, Llc with the FDA for Remi Robotic Navigation System.
| Device ID | K223070 |
| 510k Number | K223070 |
| Device Name: | Remi Robotic Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Fusion Robotics, LLC 168 Centennial Parkway, Unit 170 Louisville, CO 80027 |
| Contact | Sarah Braun |
| Correspondent | Sarah Braun Integrity Implants Inc. Dba Accelus 354 Hiatt Drive Palm Beach Gardens, FL 33418 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-10-28 |