Class Class II
Athena III Cervical Plate System (K230301)
Description
Athena III Cervical Plate System by Medyssey USA, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230301
Clearance Date2023-03-07
Clearance TypeSpecial
Product CodeKWQ
Regulation Number888.3060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230301
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. Athena III Cervical Plate System (K230301) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183409 | Athena II Cervical Plate System | Medyssey USA, Inc. | 2019 |
Trace the full predicate network for K230301
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.