BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60— 510(k) K123225

Substantially Equivalent

Aap Biomaterials GmbH & Co. KG

FDA 510(k) clearance K123225 for BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60, Substantially Equivalent on 2013-03-15. Applicant: Aap Biomaterials GmbH & Co. KG.

Clearance details

Applicant: Aap Biomaterials GmbH & Co. KG
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2012-10-15
Decision date: 2013-03-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dieburg, 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.