Class Class II
CoreLink Navigation Instruments (K230880)
Description
CoreLink Navigation Instruments by Corelink, LLC, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230880
Clearance Date2023-05-02
Clearance TypeSpecial
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230880
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. CoreLink Navigation Instruments (K230880) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022 |
| K220973 | CoreLink Navigation Instruments | Corelink, LLC | 2022 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments f... | Medtronic Sofamor Danek | 2017 |
Trace the full predicate network for K230880
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.