Class Class II
F3D Interbody System (K230329)
Description
F3D Interbody System by Corelink, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230329
Clearance Date2023-06-06
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230329
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. F3D Interbody System (K230329) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 |
| K202637 | F3D Corpectomy System | Corelink, LLC | 2020 |
| K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 |
| K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar System | Corelink, LLC | 2018 |
Trace the full predicate network for K230329
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.