FDA 510(k) Applications Submitted by KAREN HO

FDA 510(k) Number Submission Date Device Name Applicant
K161360 05/16/2016 U2 Total Knee System, PSA Tibial Insert UNITED ORTHOPEDIC CORPORATION
K151316 05/18/2015 U2 Hip Stem, Ti Porous Coated, Matrix United Orthopedic Corporation
K161705 06/20/2016 U2 Total Knee System E-XPE products UNITED ORTHOPEDIC CORPORATION
K152430 08/26/2015 All Poly Tibial Component UNITED ORTHOPEDIC CORPORATION
K152439 08/27/2015 U2 Bipolar Implant and 22mm Femoral Head UNITED ORTHOPEDIC CORPORATION
K152530 09/03/2015 UCP Stem UNITED ORTHOPEDIC CORPORATION
K190114 01/24/2019 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) ConvaTec Limited
K162906 10/17/2016 Flexi-Seal PROTECT Fecal Management System ConvaTec
K201347 05/21/2020 DePuy ATTUNEÖáTotal Knee System DePuy Orthopaedics, Inc.
K202098 07/29/2020 GLOBAL UNITEÖ Platform Shoulder System DePuy Ireland UC
K202472 08/28/2020 ACTIS Duofix Hip Prosthesis DePuy Orthopaedics Inc.
K120836 03/20/2012 0.9% SODIUM CHLORIDE FLISH SYRINGE AMUSA
K111034 04/13/2011 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE AM USA
K113555 12/01/2011 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE AM USA
K181290 05/16/2018 Fusion Bx 2.0 Focal Healthcare Inc.
K973036 08/14/1997 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES 3M HEALTH CARE
K202517 09/01/2020 Cytrellis Dermal Micro-Coring System Cytrellis Biosystems, Inc.


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