FDA 510(k) Applications for Medical Device Product Code: PKC ()

FDA 510(k) Applications for Medical Device Product Code "PKC"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K203100	Arthrex Inc.	Arthrex Eclipse Titanium Humeral Head	11/20/2020
K201542	Arthrex, Inc.	Arthrex Eclipse Shoulder Prosthesis System	07/08/2020
K182516	Biomet Manufacturing Corp	Comprehensive Nano Stemless Shoulder	04/22/2019
K212683	DePuy (Ireland)	GLOBAL ICON Stemless Shoulder System	01/19/2022
K193226	Encore Medical, L.P	AltiVate Anatomic Canal-Sparing (CS) Shoulder	06/03/2020
K173388	Exactech Inc	Exactech Equinoxe Stemless Shoulder	03/09/2018
K192097	Exactech, Inc.	Exactech« Equinoxe« Stemless Humeral Components	04/29/2020
K201391	FX Shoulder USA, Inc.	Easytech« Anatomical Shoulder System	02/16/2021
K203108	Ignite Orthopedics LLC	Ignite Stemless Anatomic Shoulder System	07/16/2021
K221758	LimaCorporate S.p.A	SMR Stemless Anatomic	03/17/2023
K213615	Shoulder Innovations, Inc.	Shoulder Innovations Total Shoulder System	03/11/2022
K143552	TORNIER, INC.	Simpliciti Shoulder System	03/04/2015
K220418	Tornier, Inc.	Tornier Perform Humeral System û Stemless	09/14/2022
K171858	Zimmer GmbH	Sidus Stem-Free Shoulder	12/18/2017