U2 ACETABULAR COMPONENT— 510(k) K050262

Name: FDA 510(k) clearance K050262
Creator: U.S. Food and Drug Administration
Published: 2005-08-15

Substantially Equivalent

United Orthopedic Corp.

FDA 510(k) clearance K050262 for U2 ACETABULAR COMPONENT, Substantially Equivalent on 2005-08-15. Applicant: United Orthopedic Corp.. Device class: 2.

Clearance details

Applicant: United Orthopedic Corp.
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2005-02-04
Decision date: 2005-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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K122185 — U-MOTION II ACETABULAR SYSTEM2013-02-22
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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.