Stainless Steel Orthopaedic Cable System
FDA 510(k) K875156 · Richards Medical Co., Inc.
510(k) numberK875156
Submission
- Device name
- Stainless Steel Orthopaedic Cable System
- Applicant
- Richards Medical Co., Inc.
Memphis, TN, US - Received
- December 15, 1987
- Decision date
- January 20, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. | 07/16/2026SE |
| K243905 | Stitch Cerclage Suture TapesJDQ · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/14/2025SE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional | Arthrex, Inc. | 02/20/2025SE |
| K232733 | Mbrace CableJDQ · Traditional | Medacta International S.A. | 05/03/2024SE |
| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
| K232986 | VariTrax Sternal CircumFixation SystemJDQ · Traditional | Circumfix Solutions, Inc. | 01/30/2024SE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional | Arthrex, Inc. | 08/24/2023SE |
| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
| K220765 | HS Fiber CerclageJDQ · Traditional | Riverpoint Medical, LLC | 07/26/2023SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 10/19/2022SE |
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| K896580 | Uni-Polar HeadLZY · Traditional | 02/15/1990SE |
| K895241 | Intramedullary Hip ScrewKTT · Traditional | 01/04/1990SE |
| K884824 | Tricon-M Total Knee SystemMBV · Traditional | 11/21/1989SN |
| K896204 | Zirconia Ceramic Head Add'L SizesLZO · Traditional | 11/20/1989SN |
| K895242 | Pappas Tri-Flange Ventilation TubeETD · Traditional | 11/17/1989SE |
| K893377 | Russell-Taylor Intramedullary Knee Fusion NailsHSB · Traditional | 11/16/1989SE |
| K885069 | Zirconia Ceramic Head (Yitria Stabilized)LZO · Traditional | 09/01/1989SN |
| K892366 | Porous Genesis Stemmed Tibial ComponentJWH · Traditional | 07/19/1989SN |
Questions and answers
When was Stainless Steel Orthopaedic Cable System cleared by the FDA?
Stainless Steel Orthopaedic Cable System (K875156) received a 510(k) decision of Substantially Equivalent on January 20, 1988, 36 days after the submission was received.
What is the product code of K875156?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.