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. |
K221593 |
06/02/2022 |
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus |
ConvaTec, Inc. |
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. |
K182039 |
07/30/2018 |
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay |
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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