FDA 510(k) Applications for Medical Device Product Code "JDQ"
(Cerclage, Fixation)

FDA 510(k) Number Applicant Device Name Decision Date
K180582 A & E Medical Corporation Sternal Cable System 05/31/2018
K173579 A&E Medical Corporation ThoreconÖ Fixation System 02/12/2018
K060009 ABBOTT SPINE, INC. ABBOTT SPINE UNIVERSAL CLAMP SYSTEM 03/06/2006
K081622 ABBOTT SPINE, INC. UNIVERSAL CLAMP STAINLESS STEEL SYSTEM 08/29/2008
K960651 ACU-MED, INC. CERCLAGE WIRE CRIMP BLOCK 05/03/1996
K921480 ACU-MED, INC. OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM 06/26/1992
K931246 ACUMED, INC. CERCLAGE WIRE CRIMP SLEEVE 02/22/1994
K063017 AESCULAP, INC. AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM 12/27/2006
K932687 AMERICAN MEDICAL ELECTRONICS, INC. AME(R) UNIVERSIAL CABLE SYSTEM 05/03/1994
K942300 AMERICAN MEDICAL ELECTRONICS, INC. SILKON TITANIUM CABLE SYSTEM 01/09/1995
K170206 ARTHREX, INC. Arthrex FiberTape Cerclage 11/15/2017
K882967 BAXTER HEALTHCARE CORP. BONE FIXATION WIRE 09/30/1988
K922142 BIO-TECH CO. FX-CABLELOK SYSTEM 11/20/1992
K912207 BIODYNAMIC TECHNOLOGIES, INC. FX-CABLELOK SYSTEM 07/09/1991
K915259 BIODYNAMIC TECHNOLOGIES, INC. FX-CABLELOK SYSTEM, MODIFICATION 02/07/1992
K935646 BIODYNAMIC TECHNOLOGIES, INC. FX-CABLELOK(TM) "STOP"(TROCHANTER HOOK) SYSTEM 03/09/1994
K951844 BIOMECHANIC, INC. BIOMECHANIC LOW-PROFILE CABLE SYSTEM 07/13/1995
K071271 BIOMET MANUFACTURING, INC. BIOMET CABLE SYSTEM 10/23/2007
K110039 BIOMET SPORTS MEDICINE BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM 05/03/2011
K982545 BIOMET, INC. BMP CABLE SYSTEM 10/19/1998
K133354 BIOMET, INC. PERI-PROSTHETIC CABLE SYSTEM 01/27/2014
K935950 BUCKMAN CO., INC. FX-CABLELOK CABLE/PLATE SYSTEM 03/09/1994
K915581 CODMAN & SHURTLEFF, INC. CODMAN SOF'WIRE (TM) KIT 01/16/1992
K923869 CODMAN & SHURTLEFF, INC. CODMAN SOF'WIRE TITANIUM CABLE SYSTEM 05/12/1993
K926116 CODMAN & SHURTLEFF, INC. CODMAN SOFWIRE(TM) KIT 03/30/1993
K101484 DALLEN MEDICAL COMPRESSYN BAND 04/01/2011
K130431 DALLEN MEDICAL, INC. COMPRESSYN BAND 07/25/2013
K913735 DANEK MEDICAL, INC. SONGER(TM) CABLE SYSTEM 11/18/1991
K903676 DANEK MEDICAL, INC. STERNOTOMY CABLE, SONGER CABLE SYSTEM 09/10/1990
K892411 DENTSPLY INTL. MENNEN BONE FIXATION DEVICE 01/05/1990
K934557 DEPUY, INC. CONTROL CABLE SYSTEM 02/25/1994
K914693 DEPUY, INC. DEPUY (NITINO) GUIDE WIRE 12/09/1991
K143716 DSM BIOMEDICAL DSM Biomedical DPR Cable 10/29/2015
K932024 ENCORE ORTHOPEDICS, INC. CCG CERCLAGE SYSTEM 02/14/1995
K110541 FIGURE 8 SURGICAL, INCORPORATED FIGURE 8 STERNOTOMY CLOSURE DEVICE 07/06/2011
K151888 FRONTIER MEDICAL DEVICES, INC. Frontier Medical Devices In-line Orthopedic Cable Cerclage System 10/30/2015
K153242 FRONTIER MEDICAL DEVICES, INC. Frontier Medical Devices In-Line Orthopedic Cable Cerclage System 01/13/2016
K151346 FRONTIER MEDICAL DEVICES, INC. Frontier Medical Devices Posterior Cable Screw System 08/20/2015
K934059 HOWMEDICA CORP. DALL MILES SYSTEM GROOVED BUTTON 08/01/1994
K945294 HOWMEDICA CORP. DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE 03/07/1995
K934058 HOWMEDICA CORP. DALL MILES SYSTEM MINICLEAT 02/23/1994
K971741 HOWMEDICA CORP. DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE 07/16/1997
K961283 HOWMEDICA CORP. DALL-MILES HOMOGENOUS VITALLIUM CABLE 05/22/1996
K961569 HOWMEDICA CORP. DALL-MILES STAINLESS STEEL BEADED CABLE 06/24/1996
K953818 HOWMEDICA CORP. DALL-MILES SUTURE/BEADED CABLE 10/12/1995
K962162 HOWMEDICA CORP. DALL-MILES TROCHANTER CABLE SUPERGRIP 08/14/1996
K984432 HOWMEDICA OSTEONICS CORP. DALL-MILES CABLE GRIP (A-GRIP) 02/24/1999
K121541 IMPLANET S.A. JAZZ SYSTEM 09/13/2012
K944529 INTERMEDICS ORTHOPEDICS CABLE-EASE PLATE AND CABLE SYSTEM 02/17/1995
K950027 INTERMEDICS ORTHOPEDICS CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK 03/06/1995
K103797 K2M, INC. K2M COCR WIRE 05/20/2011
K102834 KINAMED INCORPORATED ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) 01/12/2011
K030256 KINAMED, INC. ISO-ELASTIC CERCLAGE SYSTEM 10/21/2003
K181749 Kinamed, Incorporated SuperCable« Iso-ElasticÖ Cerclage System 08/01/2018
K850631 KIRSCHNER MEDICAL CORP. KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES 05/01/1985
K151983 KLS MARTIN L.P. KLS Martin LSS Plating System 04/06/2016
K910128 LEVTECH, INC. LEVTECH TITANIUM BONE WIRE 06/18/1991
K112736 MEDICREA INTERNATIONAL PASS LP SPINAL 02/01/2012
K983976 METAGEN, L.L.C. METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM 12/30/1998
K001254 ORTHOMATRIX, INC. ORTHOMATRIX, INC. CERCLAGE SYSTEM 12/13/2000
K874919 ORTHOMET, INC. ORTHOMET WIRE FOR SUTURE, CERCLAGE 01/07/1988
K023564 OSSEUS, LLC OSSE-LIGN 03/11/2003
K040199 OSSEUS, LLC OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS 02/20/2004
K914374 OSTEO AG OSTEO CERCLAGE WIRE 12/30/1991
K925447 OSTEO TECHNOLOGY, INC. OTI ORTHOPEDIC WIRE SYSTEM 06/29/1993
K962132 OSTEONICS CORP. SILKON STAINLESS STEEL CABLE SYSTEM 08/08/1996
K972327 PACIFIC MATERIALS AND INTERFACES METAGEN ACTIVELOCK CERCLAGE SYSTEM 08/11/1997
K000694 PECTOFIX, INC. PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) 05/11/2000
K003951 PECTOFIX, INC. PECTOFIX STERNAL REPAIR WIRE 03/21/2001
K980690 PIONEER SURGICAL TECHNOLOGY CABLE SCREW WITH INTEGRAL CRIMP 05/22/1998
K974016 PIONEER SURGICAL TECHNOLOGY CERCLAGE CABLE WITH HEX BUTTON 12/19/1997
K940729 PIONEER SURGICAL TECHNOLOGY PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES 12/21/1994
K993286 PIONEER SURGICAL TECHNOLOGY PIONEER SILICOAT STERNAL CABLE 11/23/1999
K961267 PIONEER SURGICAL TECHNOLOGY PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE 06/27/1996
K992616 PIONEER SURGICAL TECHNOLOGY SDB CERCLAGE SYSTEM 10/27/1999
K941213 PIONEER SURGICAL TECHNOLOGY SONGER CABLE SYSTEM 04/19/1994
K922952 PIONEER SURGICAL TECHNOLOGY SONGER CABLE SYSTEM 02/23/1993
K002110 PIONEER SURGICAL TECHNOLOGY SPL CRIMP SYSTEM 10/06/2000
K935481 PIONEER SURGICAL TECHNOLOGY SPONGER CABLE SYSTEM, MODIFICATION 01/26/1994
K001709 PIONEER SURGICAL TECHNOLOGY TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 08/31/2000
K133785 PIONEER SURGICAL TECHNOLOGY, INC TRITIUM STERNAL CABLE PLATE SYSTEM 01/27/2014
K150581 Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Tritium Sternal Cable Plate System 06/04/2015
K161876 Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Tritium« Sternal Cable Plate System 09/09/2016
K973098 PLUS ORTHOPEDICS COMPRESSION CERCLAGE GUNDOLF CCG-GF 10/27/1997
K842977 RICHARDS MEDICAL CO., INC. ORTHOPAEDIC CABLE SYSTEM 10/26/1984
K875156 RICHARDS MEDICAL CO., INC. STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM 01/20/1988
K090686 SIC BREVETTI S.R.L. SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS 12/08/2009
K924141 SMITH & NEPHEW RICHARDS, INC. ORTHOPAEDIC POLYETHYLENE CABLE 11/30/1993
K043252 SMITH & NEPHEW, INC. CABLING SYSTEM TROCHANTER HOOK 01/14/2005
K031162 SMITH & NEPHEW, INC. SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM 05/01/2003
K920201 SOFAMOR DANEK MFG., INC. TITANIUM ALLOY SONGER CABLE SYSTEM 04/08/1992
K925812 SOFAMOR DANEK MFG., INC. TITANIUM SONGER CABLE SYSTEM 03/24/1993
K974020 SPINAL CONCEPTS, INC. SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM 12/19/1997
K120177 SPINAL ELEMENTS, INC. SPINAL ELEMENTS CERCLAGE SYSTEM 07/03/2012
K930015 STONY BROOK SURGICAL INNOVATIONS, INC. STERNAL BAND 05/19/1993
K935592 SURGICAL ACCESSORIES, INC. SURGICAL ACCESSORIES COCR CABLE SYSTEM 01/26/1994
K934176 SURGICAL ACCESSORIES, INC. SURGICAL ACCESSORIES LOOPED WIRE 02/22/1994
K081205 SYNTHES (USA) SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS 07/01/2008
K033816 SYNTHES (USA) SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM 03/02/2004
K050041 SYNTHES (USA) SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM 02/25/2005
K031508 SYNTHES (USA) SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM 05/30/2003
K992891 SYNTHES (USA) SYNTHES CERCLAGE POSITIONING PIN 11/02/1999
K010943 SYNTHES (USA) SYNTHES STERNAL FIXATION SYSTEM 06/27/2001
K110789 SYNTHES (USA) SYNTHES STERNAL ZIPFIX SYSTEM 07/28/2011
K953777 SYNTHES (USA) SYNTHES WIRE MOUNT 03/08/1996
K172975 Synthes (USA) Products LLC/DePuy Orthopaedics Inc DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins û MR Conditional, DePuy Synthes Variable Angle Positioning Pins û MR Conditional, DePuy Synthes Wire Mount û MR Conditional, DePuy Synthes Cerclage Positioning Pin û MR Conditional 06/21/2018
K882890 THACKRAY USA WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM 08/08/1988
K970084 TURNKEY INTERGRATION USA, INC. LINK CERCLAGE WIRE SYSTEM 03/13/1997
K993903 WHITESIDE BIOMECHANICS, INC. WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 02/14/2000
K880309 WINN HIRSCH & ASSOC. TYPE 316L STAINLESS STEEL WIRE 02/29/1988
K091190 ZIMMER SPINE, INC UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 07/30/2009
K151848 ZIMMER, INC. Cable-Ready« Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System 01/15/2016
K150889 ZIMMER, INC. Suture Wires and Wire Loops 07/01/2015


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