Cable-Ready® Cable Grip System
FDA 510(k) K261271 · Pioneer Surgical Technology, Inc.
510(k) numberK261271
Submission
- Device name
- Cable-Ready® Cable Grip System
- Applicant
- Pioneer Surgical Technology, Inc.
Marquette, MI, US - Received
- April 17, 2026
- Decision date
- July 16, 2026
- 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
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| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
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| K133455 | Crossfuse II Coronal Taper, Crossfuse II HyperlordoticMAX · Traditional | 03/27/2014SE |
| K133623 | C-PlusODP · Traditional | 02/10/2014SE |
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| K131724 | Pioneer Maxfuse Vertebral Body Replacement DeviceMQP · Traditional | 12/24/2013SE |
Questions and answers
When was Cable-Ready® Cable Grip System cleared by the FDA?
Cable-Ready® Cable Grip System (K261271) received a 510(k) decision of Substantially Equivalent on July 16, 2026, 90 days after the submission was received.
What is the product code of K261271?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.