Class Class II
S.I.N. Instrument Kits (K241378)
Description
S.I.N. Instrument Kits by S.I.N. - Sistema DE Implante Nacional S.A., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241378
Clearance Date2024-07-12
Clearance TypeTraditional
Product CodeKCT
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241378
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. S.I.N. Instrument Kits (K241378) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212404 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacion... | 2021 |
| K201688 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacion... | 2020 |
Trace the full predicate network for K241378
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.