Class Class II
Anatase Spine Surgery Navigation System (K230783)
Description
Anatase Spine Surgery Navigation System by Remex Medical Corp., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230783
Clearance Date2023-04-21
Clearance TypeSpecial
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230783
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. Anatase Spine Surgery Navigation System (K230783) cites 2 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-... | Remex Medical Corporation | 2022 |
| K180523 | INTAI Surgery Navigation System | Intai Technology Corporation | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Sur... | Remex Medical Corp. | 2025 |
| K243560 | Remex Spine Surgery Navigation Instrument | Remex Medical Corp. | 2024 |
| K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | 2024 |
Trace the full predicate network for K230783
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.