Class Class II
Remi Robotic Navigation System (K223350)
Description
Remi Robotic Navigation System by Fusion Robotics, LLC, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223350
Clearance Date2023-03-13
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223350
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Remi Robotic Navigation System (K223350) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223070 | Remi Robotic Navigation System | Fusion Robotics, LLC | 2022 |
| K171651 | EXCELSIUS GPS | Globus Medical, Inc. | 2017 |
| K122234 | OEC 9900 ELITE | Ge Healthcare Surgery GE Oec Medica... | 2012 |
Trace the full predicate network for K223350
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.