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 a cranioplasty plate under GWO, preformed alterable plates for repairing skull defects. "Alterable" is the key word in the code: the surgeon can trim or shape the plate during surgery, unlike the non-alterable plates in the neighboring GXN code.

Class II, 21 CFR 882.5320, Neurology panel. It's a Special 510(k), meaning CraniUS was modifying a plate it already had cleared.

CraniUS filed from Baltimore, Maryland. Review took 28 days (August 14 to September 11, 2026), right on the timeline the Special pathway targets.

Clearance details

Applicant: CraniUS, LLC
Product code: 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

view all

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.