Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)— 510(k) K171161

Substantially Equivalent

Dimensional Bioceramics, LLC

FDA 510(k) clearance K171161 for Dimensional Bioceramics Calcium Sulfate Device (DB-CSD), Substantially Equivalent on 2017-09-25. Applicant: Dimensional Bioceramics, LLC.

Clearance details

Applicant: Dimensional Bioceramics, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2017-04-20
Decision date: 2017-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scotts Valley, CA, 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.