VSP PEEK Cranial Implant— 510(k) K231834

Substantially Equivalent

3D Systems, Inc.

FDA 510(k) clearance K231834 for VSP PEEK Cranial Implant, Substantially Equivalent on 2024-04-04. Applicant: 3D Systems, Inc..

Clearance details

Applicant: 3D Systems, Inc.
Product code: Code GWO
Advisory panel: Neurology
Date received: 2023-06-22
Decision date: 2024-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.