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 |
| K193479 | A&E Medical Corporation | Sternal Cable System | 03/23/2020 |
| K181607 | A&E Medical Corporation | Thorecon Rigid Fixation System | 10/12/2018 |
| 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 |
| K063017 | AESCULAP, INC. | AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM | 12/27/2006 |
| K230976 | Arthrex, Inc | Arthrex Radiopaque FiberTape Cerclage sutures | 08/24/2023 |
| K170206 | ARTHREX, INC. | Arthrex FiberTape Cerclage | 11/15/2017 |
| 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 |
| K173910 | Cable Fix Medical LLC | Impress SFS System | 09/14/2018 |
| K101484 | DALLEN MEDICAL | COMPRESSYN BAND | 04/01/2011 |
| K130431 | DALLEN MEDICAL, INC. | COMPRESSYN BAND | 07/25/2013 |
| K143716 | DSM BIOMEDICAL | DSM Biomedical DPR Cable | 10/29/2015 |
| 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 |
| K231333 | Globus Medical Inc. | STRETTOÖ Cable System | 08/04/2023 |
| 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 |
| K962162 | HOWMEDICA CORP. | DALL-MILES TROCHANTER CABLE SUPERGRIP | 08/14/1996 |
| K984432 | HOWMEDICA OSTEONICS CORP. | DALL-MILES CABLE GRIP (A-GRIP) | 02/24/1999 |
| K202016 | Howmedica Osteonics Corp., dba Stryker Orthopaedics | Dall-Miles« Cable System | 10/16/2020 |
| K121541 | IMPLANET S.A. | JAZZ SYSTEM | 09/13/2012 |
| 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 |
| K151983 | KLS MARTIN L.P. | KLS Martin LSS Plating System | 04/06/2016 |
| K112736 | MEDICREA INTERNATIONAL | PASS LP SPINAL | 02/01/2012 |
| K983976 | METAGEN, L.L.C. | METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM | 12/30/1998 |
| K211613 | Neos Surgery SL | Stern Fix Sternal Stabilization System | 01/19/2022 |
| K221795 | Neos Surgery SL | STERN FIX Sternal Stabilization System | 10/19/2022 |
| K001254 | ORTHOMATRIX, INC. | ORTHOMATRIX, INC. CERCLAGE SYSTEM | 12/13/2000 |
| 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 |
| 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 |
| 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 |
| K002110 | PIONEER SURGICAL TECHNOLOGY | SPL CRIMP SYSTEM | 10/06/2000 |
| 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 |
| K201497 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) | EVOS Cabling System | 10/28/2020 |
| K150581 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) | Tritium Sternal Cable Plate System | 06/04/2015 |
| K193468 | Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) | Tritium Sternal Cable Plate System | 03/12/2020 |
| 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 |
| K220765 | Riverpoint Medical, LLC | HS Fiber Cerclage | 07/26/2023 |
| K090686 | SIC BREVETTI S.R.L. | SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS | 12/08/2009 |
| K043252 | SMITH & NEPHEW, INC. | CABLING SYSTEM TROCHANTER HOOK | 01/14/2005 |
| K031162 | SMITH & NEPHEW, INC. | SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM | 05/01/2003 |
| K974020 | SPINAL CONCEPTS, INC. | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM | 12/19/1997 |
| K120177 | SPINAL ELEMENTS, INC. | SPINAL ELEMENTS CERCLAGE SYSTEM | 07/03/2012 |
| 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 |
| 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 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
