Class Class II
Integrity™ Implant (K250997)
Description
Integrity™ Implant by Anika Therapeutics, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250997
Clearance Date2025-06-17
Clearance TypeTraditional
Product CodeOWX
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250997
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. Integrity™ Implant (K250997) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223538 | Integrity Implant | Anika Therapeutics, Inc. | 2023 |
Trace the full predicate network for K250997
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.