510(k) Report

Devices descending from K962548

6 later devices reach BSM Bone Substitute Material Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+1K983104Norian Periodontal/Dental Cement (PDC)Norian Corp.19992—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K100883CarrigenEtex Corp.20100—
+2K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+3K213260CMFlexTMDimension Inx Corp.20220—