Class Class II
FIX-C 3D Ti ACIF System (K243915)
Description
FIX-C 3D Ti ACIF System by Jeil Medical Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243915
Clearance Date2025-02-18
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243915
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. FIX-C 3D Ti ACIF System (K243915) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | 2024 |
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion Sys... | Gbs Commonwealth Co., Ltd. | 2023 |
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | Jeil Medical Corporation | 2021 |
Trace the full predicate network for K243915
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.