SuperCable® Iso-Elastic Cerclage System— 510(k) K181749

Substantially Equivalent

Kinamed, Incorporated

FDA 510(k) clearance K181749 for SuperCable® Iso-Elastic Cerclage System, Substantially Equivalent on 2018-08-01. Applicant: Kinamed, Incorporated.

Clearance details

Applicant: Kinamed, Incorporated
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2018-07-02
Decision date: 2018-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

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.