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GWO — Plate, Cranioplasty, Preformed, Alterable Class II

FDA Device Classification

Classification Details

Product Code
GWO
Device Class
Class II
Regulation Number
882.5320
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250297techfit digital surgeryTECHFIT Patient-Specific Cranial SystemOctober 27, 2025
K250334kelyniam globalFusion Craniofacial Implant; Fusion Skull ImplantJuly 25, 2025
K2318343d systemsVSP PEEK Cranial ImplantApril 4, 2024
K212391mci medical concept innovationMCI-Neuro Fixation SystemOctober 21, 2022
K210360osteonic coNeuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), NeuJanuary 27, 2022
K203055strykerStryker PEEK Customized Cranial Implant KitFebruary 9, 2021
K190811osteonic coOptimus NEURO System - Sterile KitNovember 27, 2019
K190229strykerStryker PEEK Customized Cranial Implant KitJuly 11, 2019
K182711kelyniam globalCustomized Craniofacial Implant (CCI), Customized Skull Implant (CSI)May 21, 2019
K183352osteonic coOptimus Neuro SystemJanuary 2, 2019
K182425stryker leibinger gmbh and co kgUniversal Mesh - SterileNovember 6, 2018
K170725strykerStryker Universal MeshNovember 13, 2017
K170368jeil medical corporationSterile NS SystemSeptember 11, 2017
K161821strykerStryker Universal MeshDecember 8, 2016
K161446ceremedBiopor Porous Polyethylene ImplantsSeptember 27, 2016
K153248strykerPEEK Customized Cranial ImplantMarch 10, 2016
K152076strykerPEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityAugust 26, 2015
K141123alliance partnersALLIANCE SPINE RAAS CRANIAL PLATING SYSTEMFebruary 27, 2015
K141911osteonic coOPTIMUS NEURO SYSTEMFebruary 10, 2015
K141644innovasisINNOVASIS CRANIAL SYSTEMNovember 7, 2014