Class Class II
Legend® Acetabular Shell (K242833)
Description
Legend® Acetabular Shell by Ortho Development Corp., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242833
Clearance Date2024-10-11
Clearance TypeSpecial
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242833
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. Legend® Acetabular Shell (K242833) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161080 | Escalade Legend Acetabular Shell | Ortho Development Corporation | 2016 |
Trace the full predicate network for K242833
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.