FX-CABLELOK SYSTEM, MODIFICATION— 510(k) K915259

Name: FDA 510(k) clearance K915259
Creator: U.S. Food and Drug Administration
Published: 1992-02-07

Substantially Equivalent

Biodynamic Technologies, Inc.

FDA 510(k) clearance K915259 for FX-CABLELOK SYSTEM, MODIFICATION, Substantially Equivalent on 1992-02-07. Applicant: Biodynamic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Biodynamic Technologies, Inc.
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 1991-11-19
Decision date: 1992-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, VA, US

Download summary PDF View 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, 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.