3D-Cut— 510(k) K212237

Substantially Equivalent

3D-Side S.A.

FDA 510(k) clearance K212237 for 3D-Cut, Substantially Equivalent on 2021-11-29. Applicant: 3D-Side S.A..

Clearance details

Applicant: 3D-Side S.A.
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2021-07-19
Decision date: 2021-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mont-Saint-Guibert, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

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.