Ortho System— 510(k) K161884

Substantially Equivalent

3Shape A/S

FDA 510(k) clearance K161884 for Ortho System, Substantially Equivalent on 2017-04-19. Applicant: 3Shape A/S.

Clearance details

Applicant: 3Shape A/S
Product code: Code MQC
Advisory panel: Unknown
Date received: 2016-07-11
Decision date: 2017-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.