FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)— 510(k) K030972

Name: FDA 510(k) clearance K030972
Creator: U.S. Food and Drug Administration
Published: 2003-05-30

Substantially Equivalent

Disc-O-Tech Medical Technologies, Ltd.

FDA 510(k) clearance K030972 for FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH), Substantially Equivalent on 2003-05-30. Applicant: Disc-O-Tech Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Disc-O-Tech Medical Technologies, Ltd.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2003-03-28
Decision date: 2003-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Herzelia, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.