FDA 510(k) Applications Submitted by MICROPORT ORTHOPEDICS INC.

FDA 510(k) Number Submission Date Device Name Applicant
K200007 01/02/2020 PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar MicroPort Orthopedics Inc.
K173776 12/12/2017 BIOLOX delta Option and Extra-long Heads MicroPort Orthopedics Inc.
K140676 03/18/2014 PROFEMUR TL CLASSIC LONG NECK HIP STEMS MICROPORT ORTHOPEDICS INC.
K141235 05/13/2014 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS MICROPORT ORTHOPEDICS INC.
K142119 08/04/2014 PROCOTYL L-O ACETABULAR SYSTEM MICROPORT ORTHOPEDICS INC.
K140735 03/24/2014 EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS MICROPORT ORTHOPEDICS INC.
K142550 09/10/2014 EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments MICROPORT ORTHOPEDICS INC.
K143366 11/24/2014 ADVANCE Porous Coated Spiked Tibial Base MicroPort Orthopedics Inc.
K202705 09/16/2020 Prime and DYNASTY« Additive Manufacturing Shells MicroPort Orthopedics Inc.
K213816 12/07/2021 MPO Hip Instruments MicroPort Orthopedics Inc.
K213817 12/07/2021 MPO Knee Instruments; MPO PROPHECY Knee Instruments MicroPort Orthopedics Inc.
K182125 08/06/2018 EVOLUTION Stemmed CS Femur MicroPort Orthopedics Inc.
K201519 06/08/2020 PROFEMUR« GLADIATOR« Cemented Classic Stem MicroPort Orthopedics Inc.
K150302 02/06/2015 PROFEMUR Preserve Classic Stem MICROPORT ORTHOPEDICS INC.
K171389 05/11/2017 EVOLUTION Revision CCK System MicroPort Orthopedics Inc.
K140043 01/08/2014 DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD MICROPORT ORTHOPEDICS INC.
K230563 03/01/2023 EVOLUTION« Hinge Knee System MicroPort Orthopedics Inc.
K180798 03/27/2018 Prime Acetabular Cup System MicroPort Orthopedics Inc.
K181598 06/18/2018 Prime E-CLASS XLPE Liner MicroPort Orthopedics Inc.
K191632 06/19/2019 PROFEMUR TL2 Stems MicroPort Orthopedics Inc.
K190123 01/25/2019 MicroPort CoCr Femoral Heads MicroPort Orthopedics Inc.
K201157 04/30/2020 Prime BIOFOAM« Multi-Hole Shells MicroPort Orthopedics Inc.


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