FDA 510(k) Applications Submitted by Kristina Hall

FDA 510(k) Number Submission Date Device Name Applicant
K220136 01/18/2022 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc.
K190498 02/28/2019 Fortilink« IBF System with TETRAfuse«3D Technology, include the following designs: Fortilink«-TS IBF System, Fortilink«-L I BF System, Fortilink«-C IBF System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
K142070 07/30/2014 FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS RTI SURGICAL, INC.
K222564 08/24/2022 Treace Medical Concepts (TMC) Hammertoe Fixation System Treace Medical Concepts, Inc.
K213036 09/21/2021 Treace Medical Concepts (TMC) Screw Fixation System Treace Medical Concepts, Inc.


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