CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE— 510(k) K062572

Substantially Equivalent

Custom Scientific

FDA 510(k) clearance K062572 for CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE, Substantially Equivalent on 2007-05-11. Applicant: Custom Scientific.

Clearance details

Applicant: Custom Scientific
Product code: Code MQN
Advisory panel: Dental
Date received: 2006-08-31
Decision date: 2007-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chevy Chase, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

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.