VSP Orthopedics System— 510(k) K250711

Substantially Equivalent

3D Systems, Inc.

FDA 510(k) clearance K250711 for VSP Orthopedics System, Substantially Equivalent on 2025-12-05. Applicant: 3D Systems, Inc..

Clearance details

Applicant: 3D Systems, Inc.
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2025-03-10
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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.