Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (K223719)
Description
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System by Aegis Spine, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223719
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. Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (K223719) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fix... | Aegis Spine, Inc. | 2022 |
| K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervica... | Aegis Spine | 2021 |
| K143271 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar... | L&K BIOMED Co., Ltd. | 2023 |
Trace the full predicate network for K223719
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.