510(k) Report

Devices descending from K080507

9 later devices reach Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111323Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsSynthes, Inc.20112—
+1K081531Aoc Soluble Implant MaterialCeremed, Inc.20085—
+2K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials20141—
+2K120220Adaptain Soluble Implant MaterialCeremed, Inc.20122—
+2K103047Ceretene Soluble Implant MaterialCeremed, Inc.20110—
+2K082245Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LVCeremed, Inc.20080—
+3K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.20160—
+3K122561Adaptain Fastwrap, Envelock, GraftainCeremed, Inc.20121—
+4K132198Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc.20130—