Class Class II
Newclip Patient-matched instrumentation non sterile PSI (K240415)
Description
Newclip Patient-matched instrumentation non sterile PSI by Newclip Technics, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240415
Clearance Date2024-11-07
Clearance TypeTraditional
Product CodePBF
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240415
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. Newclip Patient-matched instrumentation non sterile PSI (K240415) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023 |
| K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025 |
Trace the full predicate network for K240415
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.