VERTECEM II CEMENT KIT— 510(k) K121876

Substantially Equivalent

Aap Biomaterials GmbH

FDA 510(k) clearance K121876 for VERTECEM II CEMENT KIT, Substantially Equivalent on 2012-10-19. Applicant: Aap Biomaterials GmbH.

Clearance details

Applicant: Aap Biomaterials GmbH
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2012-06-27
Decision date: 2012-10-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dieburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.