FDA Product Code
FDA Product Code JDQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3010
510(k) Clearances — 130 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026-07-16 | Traditional | PDF ↗ |
| K243905 | Stitch Cerclage Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 | Traditional | PDF ↗ |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. | 2025-02-20 | Traditional | PDF ↗ |
| K232733 | Mbrace Cable | Medacta International S.A. | 2024-05-03 | Traditional | PDF ↗ |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | 2024-03-13 | Traditional | PDF ↗ |
| K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | 2024-01-30 | Traditional | PDF ↗ |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | 2023-08-24 | Traditional | PDF ↗ |
| K231333 | STRETTO Cable System | Globus Medical, Inc. | 2023-08-04 | Traditional | PDF ↗ |
| K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | 2023-07-26 | Traditional | PDF ↗ |
| K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | 2022-10-19 | Traditional | PDF ↗ |
| K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | 2022-01-19 | Traditional | PDF ↗ |
| K201497 | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-10-28 | Traditional | PDF ↗ |
| K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-10-16 | Traditional | PDF ↗ |
| K193479 | Sternal Cable System | A & E Medical Corporation | 2020-03-23 | Traditional | PDF ↗ |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-03-12 | Traditional | PDF ↗ |
| K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | 2018-10-12 | Traditional | PDF ↗ |
| K173910 | Impress SFS System | Cable Fix Medical, LLC | 2018-09-14 | Traditional | PDF ↗ |
| K181749 | SuperCable® Iso-Elastic Cerclage System | Kinamed, Incorporated | 2018-08-01 | Special | PDF ↗ |
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins MR Conditional, DePuy Synthes Wire Mount MR Conditional, DePuy Synthes Cerclage Positioning Pin MR Conditional | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018-06-21 | Traditional | PDF ↗ |
| K180582 | Sternal Cable System | A & E Medical Corporation | 2018-05-31 | Traditional | PDF ↗ |
| K173579 | Thorecon Fixation System | A & E Medical Corporation | 2018-02-12 | Traditional | PDF ↗ |
| K170206 | Arthrex FiberTape Cerclage | Arthrex, Inc. | 2017-11-15 | Traditional | PDF ↗ |
| K161876 | Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016-09-09 | Special | PDF ↗ |
| K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016-04-06 | Traditional | PDF ↗ |
| K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | Zimmer, Inc. | 2016-01-15 | Traditional | PDF ↗ |
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System | Frontier Medical Devices, Inc. | 2016-01-13 | Traditional | PDF ↗ |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage System | Frontier Medical Devices, Inc. | 2015-10-30 | Traditional | PDF ↗ |
| K143716 | DSM Biomedical DPR Cable | Dsm Biomedical | 2015-10-29 | Traditional | PDF ↗ |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Frontier Medical Devices, Inc. | 2015-08-20 | Traditional | PDF ↗ |
| K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | 2015-07-01 | Traditional | PDF ↗ |
| K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-06-04 | Traditional | PDF ↗ |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | Pioneer Surgical Technology, Inc. | 2014-01-27 | Traditional | PDF ↗ |
| K133354 | PERI-PROSTHETIC CABLE SYSTEM | Biomet, Inc. | 2014-01-27 | Traditional | PDF ↗ |
| K130431 | COMPRESSYN BAND | Dallen Medical, Inc. | 2013-07-25 | Traditional | PDF ↗ |
| K121541 | JAZZ SYSTEM | Implanet, S.A. | 2012-09-13 | Traditional | PDF ↗ |
| K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM | Spinal Elements, Inc. | 2012-07-03 | Traditional | PDF ↗ |
| K112736 | PASS LP SPINAL | Medicrea International | 2012-02-01 | Traditional | PDF ↗ |
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM | Synthes (Usa) | 2011-07-28 | Traditional | PDF ↗ |
| K110541 | FIGURE 8 STERNOTOMY CLOSURE DEVICE | Figure 8 Surgical, Incorporated | 2011-07-06 | Traditional | PDF ↗ |
| K103797 | K2M COCR WIRE | K2m, Inc. | 2011-05-20 | Traditional | PDF ↗ |
| K110039 | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM | Biomet Sports Medicine | 2011-05-03 | Traditional | PDF ↗ |
| K101484 | COMPRESSYN BAND | Dallen Medical | 2011-04-01 | Traditional | PDF ↗ |
| K102834 | ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) | Kinamed, Incorporated | 2011-01-12 | Special | PDF ↗ |
| K090686 | SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS | Sic Brevetti S.R.L. | 2009-12-08 | Traditional | PDF ↗ |
| K091190 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009-07-30 | Special | PDF ↗ |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | Abbott Spine, Inc. | 2008-08-29 | Special | PDF ↗ |
| K081205 | SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS | Synthes (Usa) | 2008-07-01 | Traditional | PDF ↗ |
| K071271 | BIOMET CABLE SYSTEM | Biomet Manufacturing, Inc. | 2007-10-23 | Traditional | PDF ↗ |
| K063017 | AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM | Aesculap, Inc. | 2006-12-27 | Traditional | PDF ↗ |
| K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | Abbott Spine, Inc. | 2006-03-06 | Special | PDF ↗ |
| K050041 | SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM | Synthes (Usa) | 2005-02-25 | Traditional | PDF ↗ |
| K043252 | CABLING SYSTEM TROCHANTER HOOK | Smith & Nephew, Inc. | 2005-01-14 | Traditional | PDF ↗ |
| K033816 | SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM | Synthes (Usa) | 2004-03-02 | Traditional | PDF ↗ |
| K040199 | OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS | Osseus, LLC | 2004-02-20 | Special | PDF ↗ |
| K030256 | ISO-ELASTIC CERCLAGE SYSTEM | Kinamed, Inc. | 2003-10-21 | Traditional | PDF ↗ |
| K031508 | SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM | Synthes (Usa) | 2003-05-30 | Traditional | PDF ↗ |
| K031162 | SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM | Smith & Nephew, Inc. | 2003-05-01 | Special | PDF ↗ |
| K023564 | OSSE-LIGN | Osseus, LLC | 2003-03-11 | Traditional | PDF ↗ |
| K010943 | SYNTHES STERNAL FIXATION SYSTEM | Synthes (Usa) | 2001-06-27 | Abbreviated | PDF ↗ |
| K003951 | PECTOFIX STERNAL REPAIR WIRE | Pectofix, Inc. | 2001-03-21 | Traditional | PDF ↗ |
| K001254 | ORTHOMATRIX, INC. CERCLAGE SYSTEM | Orthomatrix, Inc. | 2000-12-13 | Traditional | PDF ↗ |
| K002110 | SPL CRIMP SYSTEM | Pioneer Surgical Technology | 2000-10-06 | Traditional | PDF ↗ |
| K001709 | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 | Pioneer Surgical Technology | 2000-08-31 | Traditional | PDF ↗ |
| K000694 | PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) | Pectofix, Inc. | 2000-05-11 | Traditional | PDF ↗ |
| K993903 | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 | Whiteside Biomechanics, Inc. | 2000-02-14 | Traditional | PDF ↗ |
| K993286 | PIONEER SILICOAT STERNAL CABLE | Pioneer Surgical Technology | 1999-11-23 | Special | PDF ↗ |
| K992891 | SYNTHES CERCLAGE POSITIONING PIN | Synthes (Usa) | 1999-11-02 | Traditional | PDF ↗ |
| K992616 | SDB CERCLAGE SYSTEM | Pioneer Surgical Technology | 1999-10-27 | Traditional | PDF ↗ |
| K984432 | DALL-MILES CABLE GRIP (A-GRIP) | Howmedica Osteonics Corp. | 1999-02-24 | Traditional | PDF ↗ |
| K983976 | METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM | Metagen, LLC | 1998-12-30 | Traditional | PDF ↗ |
| K982545 | BMP CABLE SYSTEM | Biomet, Inc. | 1998-10-19 | Traditional | PDF ↗ |
| K980690 | CABLE SCREW WITH INTEGRAL CRIMP | Pioneer Surgical Technology | 1998-05-22 | Traditional | PDF ↗ |
| K974016 | CERCLAGE CABLE WITH HEX BUTTON | Pioneer Surgical Technology | 1997-12-19 | Traditional | PDF ↗ |
| K974020 | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM | Spinal Concepts, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K973098 | COMPRESSION CERCLAGE GUNDOLF CCG-GF | Plus Orthopedics | 1997-10-27 | Traditional | PDF ↗ |
| K972327 | METAGEN ACTIVELOCK CERCLAGE SYSTEM | Pacific Materials and Interfaces | 1997-08-11 | Traditional | PDF ↗ |
| K971741 | DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE | Howmedica Corp. | 1997-07-16 | Traditional | PDF ↗ |
| K970084 | LINK CERCLAGE WIRE SYSTEM | Turnkey Intergration USA, Inc. | 1997-03-13 | Traditional | PDF ↗ |
| K962162 | DALL-MILES TROCHANTER CABLE SUPERGRIP | Howmedica Corp. | 1996-08-14 | Traditional | PDF ↗ |
| K962132 | SILKON STAINLESS STEEL CABLE SYSTEM | Osteonics Corp. | 1996-08-08 | Traditional | PDF ↗ |
| K961267 | PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE | Pioneer Surgical Technology | 1996-06-27 | Traditional | PDF ↗ |
| K961569 | DALL-MILES STAINLESS STEEL BEADED CABLE | Howmedica Corp. | 1996-06-24 | Traditional | PDF ↗ |
| K961283 | DALL-MILES HOMOGENOUS VITALLIUM CABLE | Howmedica Corp. | 1996-05-22 | Traditional | PDF ↗ |
| K960651 | CERCLAGE WIRE CRIMP BLOCK | Acu-Med, Inc. | 1996-05-03 | Traditional | PDF ↗ |
| K953777 | SYNTHES WIRE MOUNT | Synthes (Usa) | 1996-03-08 | Traditional | PDF ↗ |
| K953818 | DALL-MILES SUTURE/BEADED CABLE | Howmedica Corp. | 1995-10-12 | Traditional | PDF ↗ |
| K951844 | BIOMECHANIC LOW-PROFILE CABLE SYSTEM | Biomechanic, Inc. | 1995-07-13 | Traditional | PDF ↗ |
| K945294 | DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE | Howmedica Corp. | 1995-03-07 | Traditional | PDF ↗ |
| K950027 | CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK | Intermedics Orthopedics | 1995-03-06 | Traditional | PDF ↗ |
| K944529 | CABLE-EASE PLATE AND CABLE SYSTEM | Intermedics Orthopedics | 1995-02-17 | Traditional | PDF ↗ |
| K932024 | CCG CERCLAGE SYSTEM | Encore Orthopedics, Inc. | 1995-02-14 | Traditional | PDF ↗ |
| K942300 | SILKON TITANIUM CABLE SYSTEM | American Medical Electronics, Inc. | 1995-01-09 | Traditional | PDF ↗ |
| K940729 | PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES | Pioneer Surgical Technology | 1994-12-21 | Traditional | PDF ↗ |
| K934059 | DALL MILES SYSTEM GROOVED BUTTON | Howmedica Corp. | 1994-08-01 | Traditional | PDF ↗ |
| K932687 | AME(R) UNIVERSIAL CABLE SYSTEM | American Medical Electronics, Inc. | 1994-05-03 | Traditional | PDF ↗ |
| K941213 | SONGER CABLE SYSTEM | Pioneer Surgical Technology | 1994-04-19 | Traditional | PDF ↗ |
| K935950 | FX-CABLELOK CABLE/PLATE SYSTEM | Buckman Co., Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K935646 | FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM | Biodynamic Technologies, Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K934557 | CONTROL CABLE SYSTEM | Depuy, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K934058 | DALL MILES SYSTEM MINICLEAT | Howmedica Corp. | 1994-02-23 | Traditional | PDF ↗ |
Product code JDQ · Class II · Orthopedic. Data: openFDA.