DeviceClearance

Cable-Ready® Cable Grip System— 510(k) K261271

Substantially Equivalent

Pioneer Surgical Technology, Inc.

FDA 510(k) clearance K261271 for Cable-Ready® Cable Grip System, Substantially Equivalent on 2026-07-16. Applicant: Pioneer Surgical Technology, Inc.. Device class: 2.

Summary

Pioneer Surgical Technology's Cable-Ready Cable Grip System is filed under JDQ, fixation cerclage. The record doesn't list the system's components or materials.

Class II, 21 CFR 888.3010. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).

Pioneer Surgical filed from Marquette, Michigan. Review took 90 calendar days (April 17 to July 16, 2026).

Clearance details

Applicant
Pioneer Surgical Technology, Inc.
Product code
Product code JDQ
Device class
Class 2
Regulation
21 CFR 888.3010
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marquette, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JDQ

product code JDQ
Death
9
Injury
330
Total
339

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.