HUMELOCK II CEMENTED SHOULDER SYSTEM— 510(k) K140071

Substantially Equivalent

Fx Solutions

FDA 510(k) clearance K140071 for HUMELOCK II CEMENTED SHOULDER SYSTEM, Substantially Equivalent on 2014-07-28. Applicant: Fx Solutions.

Clearance details

Applicant: Fx Solutions
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2014-01-13
Decision date: 2014-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Viriat, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.