VSP PEEK Cranial Implant— 510(k) K231834

Name: FDA 510(k) clearance K231834
Creator: U.S. Food and Drug Administration
Published: 2024-04-04

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.. Device class: 2.

Clearance details

Applicant: 3D Systems, Inc.
Product code: Code GWO
Device class: Class 2
Regulation: 21 CFR 882.5320
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 ↗

Recent devices under product code GWO

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K262874 — CraniUS Plate2026-09-11
K261058 — CraniUS Plate2026-07-29
K250297 — TECHFIT Patient-Specific Cranial System2025-10-27
K250334 — Fusion Craniofacial Implant; Fusion Skull Implant2025-07-25
K212391 — MCI-Neuro Fixation System2022-10-21

More clearances from 3D Systems, Inc.

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K261826 — VSP System (Titanium Palatal Splint)2026-06-03
K250711 — VSP Orthopedics System2025-12-05
K243173 — Salto Talaris Ankle PSI System2024-10-25
K243174 — Cadence Ankle PSI System2024-10-25
K241148 — Salto Talaris Ankle PSI System2024-08-30

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.