CraniUS Plate

FDA 510(k) K262874 · CraniUS, LLC

Substantially Equivalent

510(k) numberK262874

Submission

Device name
CraniUS Plate
Applicant
CraniUS, LLC
Baltimore, MD, US
Received
August 14, 2026
Decision date
September 11, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWO – Plate, Cranioplasty, Preformed, Alterable
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5320
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code GWO

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K261058CraniUS PlateGWO · Traditional CraniUS, LLC07/29/2026SE
K250297TECHFIT Patient-Specific Cranial SystemGWO · Traditional Techfit Digital Surgery, Inc.10/27/2025SE
K250334Fusion Craniofacial Implant; Fusion Skull ImplantGWO · Traditional Kelyniam Global, Inc.07/25/2025SE
K231834VSP PEEK Cranial ImplantGWO · Traditional 3D Systems, Inc.04/04/2024SE
K212391MCI-Neuro Fixation SystemGWO · Traditional Mci Medical Concept Innovation, Inc.10/21/2022SE
K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional Osteonic Co., Ltd.01/27/2022SE
K203055Stryker PEEK Customized Cranial Implant KitGWO · Traditional Stryker02/09/2021SE
K190811Optimus NEURO System - Sterile KitGWO · Traditional Osteonic Co., Ltd.11/27/2019SE
K190229Stryker PEEK Customized Cranial Implant KitGWO · Traditional Stryker07/11/2019SE
K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)GWO · Traditional Kelyniam Global, Inc.05/21/2019SE

More from Kelyniam Global, Inc.

510(k)DeviceDecision
K261058CraniUS PlateGWO · Traditional 07/29/2026SE

Questions and answers

When was CraniUS Plate cleared by the FDA?

CraniUS Plate (K262874) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 28 days after the submission was received.

What is the product code of K262874?

The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.