Frontier Medical Devices In-Line Orthopedic Cable Cerclage System— 510(k) K153242

Name: FDA 510(k) clearance K153242
Creator: U.S. Food and Drug Administration
Published: 2016-01-13

Substantially Equivalent

Frontier Medical Devices, Inc.

FDA 510(k) clearance K153242 for Frontier Medical Devices In-Line Orthopedic Cable Cerclage System, Substantially Equivalent on 2016-01-13. Applicant: Frontier Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Frontier Medical Devices, Inc.
Product code: Product code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2015-11-09
Decision date: 2016-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwinn, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDQ

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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

More clearances from Frontier Medical Devices, Inc.

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K151888 — Frontier Medical Devices In-line Orthopedic Cable Cerclage System2015-10-30
K151346 — Frontier Medical Devices Posterior Cable Screw System2015-08-20
K143228 — Ancora LLC Interbody Fusion Device2015-02-26
K112700 — FRONTIER SADL INTERBODY FUSION DEVICE2012-11-01

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.