FDA 510(k) Applications Submitted by COURTNEY SMITH

FDA 510(k) Number Submission Date Device Name Applicant
K140019 01/03/2014 ARTHREX BIOSUTURE ARTHREX, INC.
K120044 01/05/2012 ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED ARTHREX, INC.
K130129 01/17/2013 UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM ARTHREX, INC.
K110123 01/18/2011 PCL TIGHTROPE ARTHREX, INC.
K990256 01/27/1999 CRX WORLD SHUNT PHOENIX BIOMEDICAL CORP.
K030468 02/12/2003 ACURA ELITE GRAVITY COMPENSATING RESERVOIR PHOENIX BIOMEDICAL CORP.
K000514 02/16/2000 RUMBAR DRAINAGE SYSTEM PHOENIX BIOMEDICAL CORP.
K160461 02/19/2016 Arthrex iBalance BiCompartmental Arthroplasty System Arthrex, Inc.
K120540 02/23/2012 BIOBOLT ARTHREX, INC.
K140476 02/26/2014 ARTHREX FIBERTAK SUTURE ANCHOR ARTHREX, INC.
K110660 03/07/2011 ARTHREX BIOCOMPOSITE SUTURETAK ARTHREX, INC.
K130675 03/13/2013 ARTHREX UNIVERS II CA HEADS ARTHREX, INC.
K070705 03/14/2007 MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 VYGON CORP.
K040707 03/18/2004 PACKAGING TRAY AND COMPONENTS VYGON US LLC
K060944 04/06/2006 NUTRISAFE 2 VYGON CORP.
K031238 04/18/2003 VARICES NEEDLE SCANDIMED. A.S.
K161108 04/20/2016 Arthrex VaultLock Glenoid ARTHREX, INC.
K991429 04/26/1999 DIAMOND II VALVE PHOENIX BIOMEDICAL CORP.
K061250 05/04/2006 MULTICATH EXPERT VYGON CORP.
K111253 05/04/2011 ARTHREX DISTAL EXTREMITY PLATE SYSTEM ARTHREX, INC.
K051248 05/16/2005 VYGON MICRO-ACCESS SAFETY INTRODUCER KIT VYGON CORP.
K021644 05/20/2002 PERF (OMMAYA STYLE) RESERVOIRS PHOENIX BIOMEDICAL CORP.
K131474 05/22/2013 ARTHREX DISTAL RADIUS PLATE SYSTEM ARTHREX, INC.
K041468 06/02/2004 PREMICATH, 1261.205 VYGON CORP.
K131633 06/04/2013 ARTHREX UNIVERS APEX ARTHREX, INC.
K151527 06/08/2015 Arthrex Univers Revers CA Heads and Adapters ARTHREX, INC.
K111661 06/14/2011 ARTHREX SCAPHOLUNATE ANCHOR ARTHREX, INC.
K101679 06/15/2010 ARTHREX PUSHLOCK ANCHORS ARTHREX, INC.
K051690 06/23/2005 VYGON NUTRILINE CATHETERS VYGON CORP.
K151732 06/26/2015 Arthrex Fracture Plates ARTHREX, INC.
K081942 07/08/2008 NEUROCATH AG VYGON NEURO
K132217 07/17/2013 ARTHREX COMPRESSION FT SCREWS ARTHREX, INC.
K112237 08/04/2011 MICROSUTURE ANCHORS ARTHREX, INC.
K172371 08/07/2017 Arthrex UNIVERS REVERS COATED BASEPLATE Arthrex, Inc.
K002476 08/11/2000 LUMBOPERITONEAL SHUNT SYSTEM PHOENIX BIOMEDICAL CORP.
K062425 08/18/2006 LIFECATH S PICC AND MIDLINE CATHETER VYGON CORP.
K112437 08/24/2011 ARTHREX FRACTURE SYSTEM ARTHREX, INC.
K052475 09/09/2005 VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS VYGON US LLC
K052564 09/19/2005 VYGON LEADER-FLEX VYGON CORP.
K033017 09/26/2003 PHOENIX INFUSION CATHETER PHOENIX BIOMEDICAL
K142863 10/01/2014 Univers Rivers Shoulder Prosthesis System Arthrex, Inc.
K052881 10/12/2005 VYGON LATEX FREE BIONECTOR VYGON CORP.
K123241 10/17/2012 ARTHREX FRACTURE PLATES ARTHREX, INC.
K103060 10/18/2010 ARTHREX TIBIAL GRAFTBOLT ARTHREX, INC.
K153115 10/28/2015 Arthrex Univers Apex, Size 5 Stem ARTHREX, INC.
K033704 11/25/2003 MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS VYGON US LLC
K024040 12/06/2002 ACCURA ELITE SHUNT SYSTEM PHOENIX BIOMEDICAL CORP.
K024101 12/12/2002 PHOENIX UNIVERSAL SHUNT SYSTEM PHOENIX BIOMEDICAL CORP.
K073493 12/12/2007 HEPATOSTAT SET VYGON CORP.
K103705 12/20/2010 LOW PROFILE SCREWS ARTHREX, INC.
K173900 12/22/2017 Arthrex Univers Revers Modular Glenoid System Arthrex Inc.


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