Class Class II
Hand Trauma Threaded Nail System (K230908)
Description
Hand Trauma Threaded Nail System by Skeletal Dynamics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230908
Clearance Date2023-04-28
Clearance TypeSpecial
Product CodeHWC
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230908
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. Hand Trauma Threaded Nail System (K230908) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220723 | Hand Trauma Screw System | Skeletal Dynamics, Inc. | 2022 |
Trace the full predicate network for K230908
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.