Class Class II
ACTIVBRAID™ (K223822)
Description
ACTIVBRAID™ by Embody, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223822
Clearance Date2023-06-02
Clearance TypeTraditional
Product CodeGAT
Regulation Number878.5000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223822
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. ACTIVBRAID™ (K223822) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K112899 | ARTHREX BIO-SUTURE | Arthrex, Inc. | 2012 |
| K091018 | ARTHREX BIOWIRE | Arthrex, Inc. | 2010 |
| K040004 | ORTHOCORD SUTURE | Depuy Mitek | 2004 |
Trace the full predicate network for K223822
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.