CERAMIC FEMORAL HEAD— 510(k) K103497

Substantially Equivalent

United Orthopedic Corp.

FDA 510(k) clearance K103497 for CERAMIC FEMORAL HEAD, Substantially Equivalent on 2011-03-04. Applicant: United Orthopedic Corp..

Clearance details

Applicant: United Orthopedic Corp.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2010-11-29
Decision date: 2011-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.