VSP® Orthopedics System— 510(k) K211244

Substantially Equivalent

3D Systems

FDA 510(k) clearance K211244 for VSP® Orthopedics System, Substantially Equivalent on 2021-11-10. Applicant: 3D Systems.

Clearance details

Applicant: 3D Systems
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2021-04-26
Decision date: 2021-11-10
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.