CraniUS Plate— 510(k) K262874

Name: FDA 510(k) clearance K262874
Creator: U.S. Food and Drug Administration
Published: 2026-09-11

Substantially Equivalent

CraniUS, LLC

FDA 510(k) clearance K262874 for CraniUS Plate, Substantially Equivalent on 2026-09-11. Applicant: CraniUS, LLC. Device class: 2.

Summary

The CraniUS Plate is filed under GWO, preformed alterable cranioplasty plates. A separate code, GXN, covers preformed non-alterable plates. The record doesn't describe this plate's design.

Class II, 21 CFR 882.5320. The Neurology panel reviewed it as a Special 510(k).

CraniUS filed from Baltimore, Maryland. Review took 28 days (August 14 to September 11, 2026).

Clearance details

Applicant: CraniUS, LLC
Product code: Product code GWO
Device class: Class 2
Regulation: 21 CFR 882.5320
Advisory panel: Neurology
Date received: 2026-08-14
Decision date: 2026-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWO

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K261058 — CraniUS Plate2026-07-29
K250297 — TECHFIT Patient-Specific Cranial System2025-10-27
K250334 — Fusion Craniofacial Implant; Fusion Skull Implant2025-07-25
K231834 — VSP PEEK Cranial Implant2024-04-04
K212391 — MCI-Neuro Fixation System2022-10-21

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.