Class Class II
BENCOX Delta Option Heads (K223828)
Description
BENCOX Delta Option Heads by Corentec Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223828
Clearance Date2023-03-16
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223828
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 Delta Option Heads (K223828) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic F... | Zimmer GmbH | 2019 |
Trace the full predicate network for K223828
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.