Songer Cable System
FDA 510(k) K941213 · Pioneer Surgical Technology
510(k) numberK941213
Submission
- Device name
- Songer Cable System
- Applicant
- Pioneer Surgical Technology
Marquette, MI, US - Received
- March 9, 1994
- Decision date
- April 19, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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
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 |
|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | 07/16/2026SE |
| K251436 | Resolve Anterior Cervical Plate SystemKWQ · Abbreviated | 07/11/2025SE |
| K222493 | CODA Anterior Cervical Plate SystemKWQ · Traditional | 11/18/2022SE |
| K211408 | CervAlign® Anterior Cervical Plate SystemKWQ · Traditional | 06/23/2021SE |
| K192396 | Streamline MIS Spinal Fixation SystemNKB · Traditional | 11/26/2019SE |
| K140696 | Streamline TL Spinal Fixation SystemNKB · Special | 04/10/2014SE |
| K133455 | Crossfuse II Coronal Taper, Crossfuse II HyperlordoticMAX · Traditional | 03/27/2014SE |
| K133623 | C-PlusODP · Traditional | 02/10/2014SE |
| K132050 | NB3D Bone Void FillerMQV · Traditional | 02/07/2014SE |
| K133785 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 01/27/2014SE |
Questions and answers
When was Songer Cable System cleared by the FDA?
Songer Cable System (K941213) received a 510(k) decision of Substantially Equivalent for Some Indications on April 19, 1994, 41 days after the submission was received.
What is the product code of K941213?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.