510(k) Report

Devices descending from K971922

106 later devices reach Innovasive 2.8MM and 3.5MM Roc EZ Suture Bone Fastener through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+9K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+9K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—