FDA 510(k) Applications Submitted by Ann Ho

FDA 510(k) Number Submission Date Device Name Applicant
K202650 09/14/2020 Medical disposable face mask non sterile Guangdong Zhong Ling Industrial Group Co., Ltd.
K020043 01/07/2002 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B ARTHREX, INC.
K050259 02/03/2005 ARTHREX BIO-PIN ARTHREX, INC.
K050358 02/14/2005 ARTHERX CORKSCREW FT II SUTURE ANCHOR ARTHREX, INC.
K110455 02/15/2011 KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS KIMBERLY-CLARK CORP.
K060478 02/23/2006 ARTHREX BIO-COMPRESSION SCREW ARTHREX, INC.
K050749 03/23/2005 ARTHREX TAK FAMILY ARTHREX, INC.
K011007 04/04/2001 TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 ARTHREX, INC.
K021434 05/06/2002 ARTHREX FIBERWIRE IN USP SIZES ARTHREX, INC.
K041189 05/06/2004 ARTHREX TRIMIT FAMILY ARTHREX, INC.
K011495 05/15/2001 ARTHREX BIO-POST AND WASHER ARTHREX, INC.
K041356 05/20/2004 ARTHREX TENODESIS SCREW FAMILY ARTHREX, INC.
K031666 05/29/2003 ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS ARTHREX, INC.
K041553 06/09/2004 ARTHREX SUTURE GRAFTING KIT ARTHREX, INC.
K041589 06/11/2004 ARTHREX FIBERWIRE WITH SILK ARTHREX, INC.
K061665 06/14/2006 ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT ARTHREX, INC.
K071622 06/14/2007 ARTHREX FIBERWIRE ARTHREX, INC.
K031945 06/24/2003 ARTHREX TRIMIT SCREW, MODEL AR-4161B ARTHREX, INC.
K061863 06/30/2006 ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY ARTHREX, INC.
K032098 07/08/2003 ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B ARTHREX, INC.
K022234 07/11/2002 ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B ARTHREX, INC.
K032245 07/22/2003 ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 ARTHREX, INC.
K122473 08/14/2012 TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 HILL-ROM
K062466 08/24/2006 ARTHREX INTERFERENCE SCREW ARTHREX, INC.
K072378 08/24/2007 PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 ARTHREX, INC.
K012923 08/31/2001 ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 ARTHREX, INC.
K052387 08/31/2005 ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX ARTHREX, INC.
K062747 09/14/2006 ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM ARTHREX, INC.
K023119 09/19/2002 BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B ARTHREX, INC.
K052607 09/22/2005 ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS ARTHREX, INC.
K052736 09/30/2005 ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT ARTHREX, INC.
K052901 10/14/2005 ARTHREX TENSIONLOK ARTHREX, INC.
K103150 10/26/2010 KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK KIMBERLY-CLARK
K113340 11/14/2011 KIMBERLY-CLARK CHILD'S FACEMASK KIMBERLY-CLARK
K063479 11/17/2006 ARTHREX PUSHLOCK ARTHREX, INC.
K143414 11/28/2014 Hill-Rom Wireless Connectivity Module HILL-ROM
K053338 12/01/2005 ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS ARTHREX, INC.
K023986 12/02/2002 ARTHREX OPES ELECTRODES AND ACCESSORIES ARTHREX, INC.
K063719 12/15/2006 ARTHREX CROSSPIN, MODEL AR-1964P ARTHREX, INC.
K014155 12/19/2001 OPENING/CLOSING WEDGE OSTETOMY PLATES ARTHREX, INC.
K053543 12/20/2005 ARTHREX ARTHOERESIS IMPLANT ARTHREX, INC.
K050634 03/09/2005 MODIFICATION TO: ARTHREX V-TAK ARTHREX, INC.
K071176 04/27/2007 MODIFICATION TO: ARTHREX INTERFERENCE SCREW ARTHREX, INC.
K111402 05/19/2011 KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL KIMBERLY-CLARK
K182700 09/27/2018 Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc
K212181 07/13/2021 ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed Phadia AB
K200814 03/30/2020 Affixus(R) Natural Nail(R) System Humeral Nail Zimmer GmbH
K231114 04/19/2023 Zimmer« Natural Nail« System Cephalomedullary Nails; Affixus« Natural Nail« Humeral Nail System Zimmer Switzerland Manufacturing GmbH
K192021 07/29/2019 NCB Polyaxial Locking Plate System Zimmer GmbH
K192217 08/15/2019 NCB Plating System Distal Femur and Proximal Tibia Zimmer GmbH
K192312 08/26/2019 Zimmer Natural Nail System Cephalomedullary Nails Zimmer GmbH
K191238 05/08/2019 Zimmer Guide Wire Devices Zimmer, Inc
K173826 12/18/2017 THP Hip Fracture Plating System Biomet, Inc.
K173646 11/27/2017 FS Ergo PaloDEx Group Oy


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