FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)— 510(k) K014072

Clearance details

Applicant

Disc-O-Tech Medical Technologies, Ltd.

Product code

Code KWY

Device class

Class 2

Regulation

21 CFR 888.3390

Advisory panel

Orthopedic

Date received

2001-12-10

Decision date

2002-03-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Washington, DC, US

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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 →