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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