Class Class II
ROSA Hip System (K231162)
Description
ROSA Hip System by Orthosoft Inc (D/B/A Zimmer Cas), an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231162
Clearance Date2023-05-23
Clearance TypeSpecial
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231162
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. ROSA Hip System (K231162) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210998 | ROSA Hip System | Orthosoft D/B/A Zimmer Cas | 2021 |
Trace the full predicate network for K231162
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.