Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

FDA 510(k) K182711 · Kelyniam Global, Inc.

Substantially Equivalent

510(k) numberK182711

Submission

Device name
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
Applicant
Kelyniam Global, Inc.
Canton, CT, US
Received
September 27, 2018
Decision date
May 21, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

510(k)DeviceApplicantDecision
K262874CraniUS PlateGWO · Special CraniUS, LLC09/11/2026SE
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

More from Stryker

510(k)DeviceDecision
K250334Fusion Craniofacial Implant; Fusion Skull ImplantGWO · Traditional 07/25/2025SE
K121755Custom Craniofacial Implant (Cci)GXN · Traditional 09/25/2012SE
K103582Kelyniam Custom Skull Implant (Csi)GXN · Traditional 04/14/2011SE

Questions and answers

When was Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) cleared by the FDA?

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (K182711) received a 510(k) decision of Substantially Equivalent on May 21, 2019, 236 days after the submission was received.

What is the product code of K182711?

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