U1 HIP SYSTEM - BIPOLAR— 510(k) K050269

Substantially Equivalent

United Orthopedic Corp.

FDA 510(k) clearance K050269 for U1 HIP SYSTEM - BIPOLAR, Substantially Equivalent on 2005-08-29. Applicant: United Orthopedic Corp..

Clearance details

Applicant: United Orthopedic Corp.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2005-02-04
Decision date: 2005-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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.