510(k) Report

Devices descending from K043427

3 later devices reach Duragen II Dural Regeneration Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+1K122791Lyoplant OnlayAesculap, Inc.20130—
+1K061208Lifecell Dural Substitute MatrixLifecell Corp.20070—