Resolve Modular Revision Hip Stem— 510(k) K242315

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K242315 for Resolve Modular Revision Hip Stem, Substantially Equivalent on 2025-05-01. Applicant: United Orthopedic Corporation.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2024-08-05
Decision date: 2025-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, 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.