Class Class II
CYGNUS-C Standalone ACIF System (K222041)
Description
CYGNUS-C Standalone ACIF System by GS Medical Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222041
Clearance Date2023-02-09
Clearance TypeTraditional
Product CodeOVE
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222041
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. CYGNUS-C Standalone ACIF System (K222041) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181115 | CxHA PEEK Cervical IBF System | Innovasis, Inc. | 2018 |
| K153517 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | 2016 |
| K131449 | COALITION SPACER | Globus Medical, Inc. | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231808 | QUASAR Standalone ACIF System | GS Medical Co., Ltd. | 2023 |
Trace the full predicate network for K222041
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.