FDA.reportPublic FDA data

510(k) K203055

Device
Stryker PEEK Customized Cranial Implant Kit
Applicant
Stryker
510(k) number
K203055
Product code
GWO
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-09
Date received
2020-10-08
Regulation
882.5320
Classification name
Plate, Cranioplasty, Preformed, Alterable
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Zainab Amini
Address
750 Trade Centre Way -Suite 200 Portage MI US 49002 49002

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GWO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.2025-10-27
K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.2025-07-25
K231834VSP PEEK Cranial Implant3D Systems, Inc.2024-04-04
K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.2022-10-21
K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)Osteonic Co., Ltd.2022-01-27
K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.2019-11-27
K190229Stryker PEEK Customized Cranial Implant KitStryker2019-07-11
K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.2019-05-21
K183352Optimus Neuro SystemOsteonic Co., Ltd.2019-01-02
K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG2018-11-06
K170725Stryker Universal MeshStryker2017-11-13
K170368Sterile NS SystemJeil Medical Corporation2017-09-11
K161821Stryker Universal MeshStryker2016-12-08
K161446Biopor Porous Polyethylene ImplantsCeremed , Inc.2016-09-27
K153248PEEK Customized Cranial ImplantStryker2016-03-10