MODIFICATION TO ESOP CO-CR FEMORAL HEADS— 510(k) K023375

Substantially Equivalent

Pro-Active Healthcare

FDA 510(k) clearance K023375 for MODIFICATION TO ESOP CO-CR FEMORAL HEADS, Substantially Equivalent on 2002-10-25. Applicant: Pro-Active Healthcare.

Clearance details

Applicant: Pro-Active Healthcare
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2002-10-08
Decision date: 2002-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.