Cerclage Cabling System— 510(k) K262960

Name: FDA 510(k) clearance K262960
Creator: U.S. Food and Drug Administration
Published: 2026-10-29

Substantially Equivalent

Pioneer Surgical Technology, Inc. dba EXALTA Group

FDA 510(k) clearance K262960 for Cerclage Cabling System, Substantially Equivalent on 2026-10-29. Applicant: Pioneer Surgical Technology, Inc. dba EXALTA Group. Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology, Inc. dba EXALTA Group
Product code: Product code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2026-08-25
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDQ

view all

K261271 — Cable-Ready® Cable Grip System2026-07-16
K243905 — Stitch Cerclage Suture Tapes2025-08-14
K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures2025-02-20
K232733 — Mbrace Cable2024-05-03
K233949 — ACCORD Cable System2024-03-13

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.