FDA.reportPublic FDA data

510(k) K212579

Device
FortiShield (Biosynthetic Wound Matrix)
Applicant
Organogenesis, Inc.
510(k) number
K212579
Product code
KGN
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-02
Date received
2021-08-16
Classification name
Wound Dressing With Animal-Derived Material(S)
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christina Nichols
Address
150 Dan Rd. Canton MA US 02021 02021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KGN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261224MatriDermMedskin Solutions Dr. Suwelack AG2026-05-14
K260532Derma-GideGeistlich Pharma AG2026-03-19
K260218LacertaMatrixLacerta Life Sciences2026-02-19
K253140CollOvine™ Wound PowderOvigenex, LLC2026-02-10
K251323Device 104 ParticulateGeistlich Pharma AG2026-01-22
K253339TheracorStimlabs, LLC2025-12-22
K252673LacertaMatrixLacerta Life Science2025-12-22
K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG2025-12-19
K242100SurgiAid Collagen Wound Dressing (HA)Maxigen Biotech, Inc.2025-10-16
K252001Collagen Wound DressingWinner Medical Co., Ltd.2025-10-10
K250397Helios Dermal ScaffoldHelios Biomedical, Inc.2025-08-15
K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited2025-07-16
K250329GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc.2025-06-25
K242985CollOvine™ Wound DressingOvigenex, LLC2025-06-20
K241904DermiSphere Dermal TemplateFesariustherapeutics, Inc.2025-01-06