JDQ — Cerclage, Fixation Class II
FDA Device Classification
Classification Details
- Product Code
- JDQ
- Device Class
- Class II
- Regulation Number
- 888.3010
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243905 | gm dos reis industria e comercio ltda | Stitch Cerclage Suture Tapes | August 14, 2025 |
| K243344 | arthrex | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape C | February 20, 2025 |
| K232733 | medacta international | Mbrace Cable | May 3, 2024 |
| K233949 | smith and nephew | ACCORD Cable System | March 13, 2024 |
| K232986 | circumfix solutions | VariTrax Sternal CircumFixation System | January 30, 2024 |
| K230976 | arthrex | Arthrex Radiopaque FiberTape Cerclage sutures | August 24, 2023 |
| K231333 | globus medical | STRETTO Cable System | August 4, 2023 |
| K220765 | riverpoint medical | HS Fiber Cerclage | July 26, 2023 |
| K221795 | neos surgery s.l | STERN FIX Sternal Stabilization System | October 19, 2022 |
| K211613 | neos surgery s.l | Stern Fix Sternal Stabilization System | January 19, 2022 |
| K201497 | pioneer surgical technology, inc. (dba rti surgical, inc.) | EVOS Cabling System | October 28, 2020 |
| K202016 | howmedica osteonics corp., dba stryker orthopaedics | Dall-Miles® Cable System | October 16, 2020 |
| K193479 | a and e medical corporation | Sternal Cable System | March 23, 2020 |
| K193468 | pioneer surgical technology, inc. (dba rti surgical, inc.) | Tritium Sternal Cable Plate System | March 12, 2020 |
| K181607 | a and e medical corporation | Thorecon Rigid Fixation System | October 12, 2018 |
| K173910 | cable fix medical | Impress SFS System | September 14, 2018 |
| K181749 | kinamed, incorporated | SuperCable® Iso-Elastic Cerclage System | August 1, 2018 |
| K172975 | synthes (usa) products, llc / depuy orthopaedics | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy | June 21, 2018 |
| K180582 | a and e medical corporation | Sternal Cable System | May 31, 2018 |
| K173579 | a and e medical corporation | Thorecon Fixation System | February 12, 2018 |