K150119

Substantially Equivalent

PALACOS R pro

Applicant: Heraeus Medical GmbH
Product code: LOD
Advisory panel: Orthopedic
Date received: 2015-01-20
Decision date: 2015-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Wehrheim, DE

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

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.