Class Class II
Conformity Stem Extension Line, #0 (K243466)
Description
Conformity Stem Extension Line, #0 by United Orthopedic Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243466
Clearance Date2025-01-06
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243466
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. Conformity Stem Extension Line, #0 (K243466) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242249 | Conformity Stem Extension Line | United Orthopedic Corporation | 2024 |
| K183312 | Conformity Stem | United Orthopedic Corporation | 2019 |
Trace the full predicate network for K243466
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.