HUMELOCK CEMENTED SHOULDER PROSTHESIS— 510(k) K111097

Substantially Equivalent

Fx Solutions

FDA 510(k) clearance K111097 for HUMELOCK CEMENTED SHOULDER PROSTHESIS, Substantially Equivalent on 2011-11-09. Applicant: Fx Solutions.

Clearance details

Applicant: Fx Solutions
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2011-04-20
Decision date: 2011-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Viriat, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.