OSTEOPAL plus— 510(k) K153737

Substantially Equivalent

Heraeus Medical GmbH

FDA 510(k) clearance K153737 for OSTEOPAL plus, Substantially Equivalent on 2016-04-22. Applicant: Heraeus Medical GmbH.

Clearance details

Applicant: Heraeus Medical GmbH
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2015-12-28
Decision date: 2016-04-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Wehrheim, DE

Download summary PDF View on FDA.gov ↗

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.