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

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.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code LPH
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 ↗

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.