Class Class II
FlexWing Anterior Cervical Plate System (K231251)
Description
FlexWing Anterior Cervical Plate System by Jeil Medical Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231251
Clearance Date2024-07-24
Clearance TypeTraditional
Product CodeKWQ
Regulation Number888.3060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231251
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. FlexWing Anterior Cervical Plate System (K231251) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | 2019 |
| K180972 | ARIX Clavicle System | Jeil Medical Corporation | 2018 |
| K140234 | ASPIRON ACP SYSTEM | U&I Corp. | 2014 |
| K030866 | SYNTHES ANTERIOR CSLP SYSTEM | Synthes (Usa) | 2003 |
Trace the full predicate network for K231251
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.