Class Class II
CORIOGRAPH Pre-Op Planning and Modeling Services (K250921)
Description
CORIOGRAPH Pre-Op Planning and Modeling Services by Blue Belt Technologies, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250921
Clearance Date2025-06-25
Clearance TypeTraditional
Product CodePBF
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250921
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. CORIOGRAPH Pre-Op Planning and Modeling Services (K250921) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 |
| K242813 | Materialise Shoulder System™, Materialise Shoulder Guide an... | Materialise NV | 2024 |
Trace the full predicate network for K250921
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.