Class Class II
Gemini Cervical Fusion Cage System (K242195)
Description
Gemini Cervical Fusion Cage System by ZheJiang Decans Medical Devices Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242195
Clearance Date2024-11-04
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242195
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. Gemini Cervical Fusion Cage System (K242195) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal ... | Medtronic Sofamor Danek | 2016 |
Trace the full predicate network for K242195
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.