PALABOND— 510(k) K022251

Substantially Equivalent

Heraeus Kulzer GmbH & Co. KG

FDA 510(k) clearance K022251 for PALABOND, Substantially Equivalent on 2003-02-26. Applicant: Heraeus Kulzer GmbH & Co. KG.

Clearance details

Applicant: Heraeus Kulzer GmbH & Co. KG
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2002-07-12
Decision date: 2003-02-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hanau, 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.