Conformity stem, cemented— 510(k) K191056

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K191056 for Conformity stem, cemented, Substantially Equivalent on 2020-01-03. Applicant: United Orthopedic Corporation.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2019-04-19
Decision date: 2020-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.