510(k) Report

Devices descending from K063648

12 later devices reach Surgi-Wrap Mast Tendon Sheet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+1K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+2K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+2K090778Mta Protective SheetXylos Corporation20092—
+2K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+3K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+3K100984Xylos Vessel GuardXylos Corporation20100—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—