Class Class II
BENCOX Mirabo Z Cup Cortinium (K223223)
Description
BENCOX Mirabo Z Cup Cortinium by Corentec Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223223
Clearance Date2023-02-27
Clearance TypeSpecial
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223223
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. BENCOX Mirabo Z Cup Cortinium (K223223) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022 |
| K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | 2022 |
| K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 |
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 |
| K120924 | BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED ... | Corentec Co., Ltd. | 2012 |
Trace the full predicate network for K223223
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.