510(k) Report

Devices descending from K950595

110 later devices reach Luhr Mandibular/Small Fixation Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—