JDQ — Cerclage, Fixation Class II
FDA product code JDQ covers "Cerclage, Fixation", a Class II medical device regulated under 21 CFR 888.3010. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261271 | pioneer surgical technology | Cable-Ready® Cable Grip System | July 16, 2026 |
| 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 |