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 |