510(k) Report

Devices descending from K980927

7 later devices reach Lactosorb Panels and Fasteners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+1K983360Macropore Protective SheetPacific Materials and Interfaces19996—
+2K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+2K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+3K121606Resorb-X GKLS-Martin L.P.20130—
+3K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+3K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—