K014072

Substantially Equivalent

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

Applicant: Disc-O-Tech Medical Technologies, Ltd.
Product code: KWY
Advisory panel: Orthopedic
Date received: 2001-12-10
Decision date: 2002-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.