DSM Biomedical Calcium Phosphate Cement— 510(k) K230054

Substantially Equivalent

Dsm Biomedical

FDA 510(k) clearance K230054 for DSM Biomedical Calcium Phosphate Cement, Substantially Equivalent on 2023-03-21. Applicant: Dsm Biomedical.

Clearance details

Applicant: Dsm Biomedical
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2023-01-06
Decision date: 2023-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.