FDA.reportPublic FDA data

510(k) K260218

Device
LacertaMatrix
Applicant
Lacerta Life Sciences
510(k) number
K260218
Product code
KGN
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-19
Date received
2026-01-23
Classification name
Wound Dressing With Animal-Derived Material(S)
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ted Bundrick
Address
7842 Hickory Flat Hwy. Woodstock GA US 30188 30188

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
K260652ColActive PlusCovalon Technologies, Ltd.2026-09-09
K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced Biomaterials2026-08-27
K260596Collagen Wound PowderVentris Medical2026-07-02
K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.2026-06-24
K253521ECMT-100 WMDEcm Therapeutics, Inc.2026-06-18
K253204CatalyzeBioTissue Holdings, Inc.2026-06-05
K253974Roosin Collagen DressingRoosin Medical Co., Ltd.2026-06-03
K254034Roosin Collagen PowderRoosin Medical Co., Ltd.2026-06-03
K261224MatriDermMedskin Solutions Dr. Suwelack AG2026-05-14
K260532Derma-GideGeistlich Pharma AG2026-03-19
K253140CollOvine™ Wound PowderOvigenex, LLC2026-02-10
K251323Device 104 ParticulateGeistlich Pharma AG2026-01-22
K252673LacertaMatrixLacerta Life Science2025-12-22
K253339TheracorStimlabs, LLC2025-12-22
K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG2025-12-19