FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH— 510(k) K122504

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K122504 for FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH, Substantially Equivalent on 2012-10-10. Applicant: United Orthopedic Corporation.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2012-08-16
Decision date: 2012-10-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

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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.