United U2 femoral head, 22mm delta ceramic head— 510(k) K221675

Name: FDA 510(k) clearance K221675
Creator: U.S. Food and Drug Administration
Published: 2022-11-04

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K221675 for United U2 femoral head, 22mm delta ceramic head, Substantially Equivalent on 2022-11-04. Applicant: United Orthopedic Corporation. Device class: 2.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2022-06-09
Decision date: 2022-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu City, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.