510(k) Report

Devices descending from K023237

12 later devices reach Xylos Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+1K081882Modification to Xylos Surgical MeshXylos Corporation200811—
+2K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+2K090880Xylos Porous Surgical MeshXylos Corporation20090—
+2K090778Mta Protective SheetXylos Corporation20092—
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+3K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+3K100984Xylos Vessel GuardXylos Corporation20100—
+4K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+4K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—