VSP® Orthopedics System— 510(k) K211244

Name: FDA 510(k) clearance K211244
Creator: U.S. Food and Drug Administration
Published: 2021-11-10

Substantially Equivalent

3D Systems

FDA 510(k) clearance K211244 for VSP® Orthopedics System, Substantially Equivalent on 2021-11-10. Applicant: 3D Systems. Device class: 2.

Clearance details

Applicant: 3D Systems
Product code: Code PBF
Device class: Class 2
Regulation: 21 CFR 888.3030
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 ↗

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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.