Class Class II
Skyway Anterior Cervical Plate System (K243015)
Description
Skyway Anterior Cervical Plate System by Kyocera Medical Technologies, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243015
Clearance Date2024-11-05
Clearance TypeTraditional
Product CodeKWQ
Regulation Number888.3060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243015
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. Skyway Anterior Cervical Plate System (K243015) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (... | 2023 |
| K190227 | Boomerang™ Anterior Cervical Plate System | Choicespine, LP | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (... | 2025 |
Trace the full predicate network for K243015
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.