Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (K251315)
Description
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II by Remex Medical Corp., an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251315
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 and Remex Spine Surgery Navigation System II (K251315) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | 2024 |
| K230783 | Anatase Spine Surgery Navigation System | Remex Medical Corp. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | 2026 |
Trace the full predicate network for K251315
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.