Class Class II
Fusion Craniofacial Implant; Fusion Skull Implant (K250334)
Description
Fusion Craniofacial Implant; Fusion Skull Implant by Kelyniam Global, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250334
Clearance Date2025-07-25
Clearance TypeTraditional
Product CodeGWO
Regulation Number882.5320
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250334
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. Fusion Craniofacial Implant; Fusion Skull Implant (K250334) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Imp... | Kelyniam Global, Inc. | 2019 |
| K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) | Kelyniam Global, Inc. | 2012 |
| K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) | Kelyniam Global, Inc. | 2011 |
Trace the full predicate network for K250334
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.