FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM— 510(k) K935646

Name: FDA 510(k) clearance K935646
Creator: U.S. Food and Drug Administration
Published: 1994-03-09

Substantially Equivalent for Some Indications

Biodynamic Technologies, Inc.

FDA 510(k) clearance K935646 for FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM, Substantially Equivalent for Some Indications on 1994-03-09. Applicant: Biodynamic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Biodynamic Technologies, Inc.
Product code: Product code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 1993-11-23
Decision date: 1994-03-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Concord, CA, 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.