Class Class II
SnugFit ASA Extension (K251933)
Description
SnugFit ASA Extension by Medacta International S.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251933
Clearance Date2025-07-01
Clearance TypeSpecial
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251933
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. SnugFit ASA Extension (K251933) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230544 | SnugFit All-Suture Anchor extension | Medacta International S.A. | 2023 |
| K203485 | SnugFit All-Suture Anchor | Medacta International S.A. | 2021 |
Trace the full predicate network for K251933
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.