Class Class U
FortiShield (Biosynthetic Wound Matrix) (K212579)
Description
FortiShield (Biosynthetic Wound Matrix) by Organogenesis, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK212579
Clearance Date2023-05-02
Clearance TypeTraditional
Product CodeKGN
FDA Database
View on FDA DatabasePredicate lineage for K212579
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. FortiShield (Biosynthetic Wound Matrix) (K212579) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove | Permeaderm, Inc. | 2016 |
| K082869 | AWBAT-S, AWBAT-D, AWBAT-M | Aubrey, Inc. | 2009 |
Trace the full predicate network for K212579
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.