Class Class II
Internal Joint Stabilizer – Elbow (K223318)
Description
Internal Joint Stabilizer - Elbow by Skeletal Dynamics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223318
Clearance Date2023-05-10
Clearance TypeTraditional
Product CodeOZI
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223318
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. Internal Joint Stabilizer – Elbow (K223318) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171590 | Distal Elbow Plating System | Skeletal Dynamics, LLC | 2017 |
| K153208 | Internal Joint Stabilizer - Elbow | Skeletal Dynamics, LLC | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231447 | Double Internal Joint Stabilizer- Elbow | Skeletal Dynamics, Inc. | 2023 |
Trace the full predicate network for K223318
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.