GLOBAL PRESS-FIT STEM— 510(k) K032385

Substantially Equivalent

Global Medical Co.

FDA 510(k) clearance K032385 for GLOBAL PRESS-FIT STEM, Substantially Equivalent on 2003-10-30. Applicant: Global Medical Co..

Clearance details

Applicant: Global Medical Co.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2003-08-04
Decision date: 2003-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, 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.