Arthrex Radiopaque FiberTape Cerclage sutures— 510(k) K230976

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K230976 for Arthrex Radiopaque FiberTape Cerclage sutures, Substantially Equivalent on 2023-08-24. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2023-04-05
Decision date: 2023-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, 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.