510(k) Report

Devices descending from K962194

7 later devices reach Mli Soft Tissue Screw & Washer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983056Innovasive Tibial FastenerInnovasive Devices, Inc.19980—
+1K981967Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System…Arthrotek/Biomet, Inc.19985—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K122437NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc WashersBiomet Sports Medicine20134—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—