Product code JDQ
- Device name
- Cerclage, Fixation
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3010
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243905 | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. | 2025-02-20 |
| K232733 | Mbrace Cable | Medacta International S.A. | 2024-05-03 |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | 2024-03-13 |
| K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | 2024-01-30 |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | 2023-08-24 |
| K231333 | STRETTO™ Cable System | Globus Medical, Inc. | 2023-08-04 |
| K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | 2023-07-26 |
| K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | 2022-10-19 |
| K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | 2022-01-19 |
| K201497 | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-10-28 |
| K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-10-16 |
| K193479 | Sternal Cable System | A & E Medical Corporation | 2020-03-23 |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-03-12 |
| K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | 2018-10-12 |
| K173910 | Impress SFS System | Cable Fix Medical, LLC | 2018-09-14 |
| K181749 | SuperCable® Iso-Elastic™ Cerclage System | Kinamed, Incorporated | 2018-08-01 |
| 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 |
| K180582 | Sternal Cable System | A & E Medical Corporation | 2018-05-31 |
| K173579 | Thorecon™ Fixation System | A & E Medical Corporation | 2018-02-12 |
| K170206 | Arthrex FiberTape Cerclage | Arthrex, Inc. | 2017-11-15 |
| K161876 | Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016-09-09 |
| K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016-04-06 |
| K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | Zimmer, Inc. | 2016-01-15 |
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System | Frontier Medical Devices, Inc. | 2016-01-13 |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage System | Frontier Medical Devices, Inc. | 2015-10-30 |
| K143716 | DSM Biomedical DPR Cable | Dsm Biomedical | 2015-10-29 |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Frontier Medical Devices, Inc. | 2015-08-20 |
| K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | 2015-07-01 |
| K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-06-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07899258600161 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-15 |
| 07899258600598 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-15 |
| 07899258600574 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600727 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600710 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600703 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600697 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600680 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600673 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600666 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600659 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600642 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600635 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600628 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600611 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07899258600604 | Versalock Periprosthetic Femur Plates System-GMReis | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 07613154490240 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036473 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036459 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036398 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036381 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013351 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013344 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013337 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490325 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490301 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490295 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490288 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490271 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490257 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |