EVOS Cabling System
FDA 510(k) K201497 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
510(k) numberK201497
Submission
- Device name
- EVOS Cabling System
- Applicant
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Marquette, MI, US - Received
- June 5, 2020
- Decision date
- October 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Neos Surgery S.L
| 510(k) | Device | Decision |
|---|---|---|
| K200513 | DAC Dynamic Active Compression PlateHRS · Traditional | 07/22/2020SE |
| K200095 | Streamline Navigated InstrumentsOLO · Traditional | 06/26/2020SE |
| K193468 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 03/12/2020SE |
| K192800 | Streamline TL Spinal Fixation SystemNKB · Traditional | 01/14/2020SE |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyMAX · Traditional | 12/20/2019SE |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs:…MAX · Traditional | 07/05/2019SE |
| K183060 | CervAlign Anterior Cervical Plate SystemKWQ · Traditional | 01/17/2019SE |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic SystemNKG · Traditional | 08/18/2017SE |
| K170830 | Unison-C Anterior Cervical Fixation SystemOVE · Traditional | 06/28/2017SE |
| K161876 | Tritium® Sternal Cable Plate SystemJDQ · Special | 09/09/2016SE |
Questions and answers
When was EVOS Cabling System cleared by the FDA?
EVOS Cabling System (K201497) received a 510(k) decision of Substantially Equivalent on October 28, 2020, 145 days after the submission was received.
What is the product code of K201497?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.