CraniUS Plate— 510(k) K261058

Name: FDA 510(k) clearance K261058
Creator: U.S. Food and Drug Administration
Published: 2026-07-29

Substantially Equivalent

CraniUS, LLC

FDA 510(k) clearance K261058 for CraniUS Plate, Substantially Equivalent on 2026-07-29. Applicant: CraniUS, LLC. Device class: 2.

Summary

CraniUS's CraniUS Plate is filed under GWO, preformed alterable cranioplasty plates. The record doesn't give materials or sizes.

Class II, 21 CFR 882.5320. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

CraniUS filed from Baltimore, Maryland. Review took 120 calendar days (March 31 to July 29, 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: 2026-03-31
Decision date: 2026-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWO

view all

K262874 — CraniUS Plate2026-09-11
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.