GWO · Class II · 21 CFR 882.5320

FDA Product Code GWO: Plate, Cranioplasty, Preformed, Alterable

Leading manufacturers include Stryker, Osteonic Co., Ltd. and Jeil Medical Corporation.

43
Total
43
Cleared
166d
Avg days
1981
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 186d avg (recent)

FDA 510(k) Cleared Plate, Cranioplasty, Preformed, Alterable Devices (Product Code GWO)

43 devices
1–24 of 43
Cleared Oct 27, 2025
TECHFIT Patient-Specific Cranial System
K250297
Techfit Digital Surgery, Inc.
Neurology · 269d
Cleared Jul 25, 2025
Fusion Craniofacial Implant
K250334
Kelyniam Global, Inc.
Neurology · 170d
Cleared Apr 04, 2024
VSP PEEK Cranial Implant
K231834
3D Systems, Inc.
Neurology · 287d
Cleared Oct 21, 2022
MCI-Neuro Fixation System
K212391
Mci Medical Concept Innovation, Inc.
Neurology · 445d
Cleared Jan 27, 2022
Neuro 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)
K210360
Osteonic Co., Ltd.
Neurology · 353d
Cleared Feb 09, 2021
Stryker PEEK Customized Cranial Implant Kit
K203055
Stryker
Neurology · 124d
Cleared Nov 27, 2019
Optimus NEURO System - Sterile Kit
K190811
Osteonic Co., Ltd.
Neurology · 243d
Cleared Jul 11, 2019
Stryker PEEK Customized Cranial Implant Kit
K190229
Stryker
Neurology · 156d
Cleared May 21, 2019
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
K182711
Kelyniam Global, Inc.
Neurology · 236d
Cleared Jan 02, 2019
Optimus Neuro System
K183352
Osteonic Co., Ltd.
Neurology · 30d
Cleared Nov 06, 2018
Universal Mesh - Sterile
K182425
Stryker Leibinger GmbH & Co KG
Neurology · 61d
Cleared Nov 13, 2017
Stryker Universal Mesh
K170725
Stryker
Neurology · 249d
Cleared Sep 11, 2017
Sterile NS System
K170368
Jeil Medical Corporation
Neurology · 217d
Cleared Dec 08, 2016
Stryker Universal Mesh
K161821
Stryker
Neurology · 160d
Cleared Mar 10, 2016
PEEK Customized Cranial Implant
K153248
Stryker
Neurology · 122d
Cleared Aug 26, 2015
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
K152076
Stryker
Neurology · 30d
Cleared Jul 02, 2014
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
K141452
Jeil Medical Corporation
Neurology · 30d
Cleared Jun 13, 2014
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462
Synthes USA Products, LLC
Neurology · 109d
Cleared Oct 17, 2013
UNIVERSAL NEURO 3 SYSTEM
K131775
Stryker
Neurology · 122d
Cleared Jan 17, 2013
RESORB-X G
K121606
KLS-Martin L.P.
Neurology · 230d
Cleared Sep 14, 2012
PEEK CUSTOMIZED CRAIAL IMPLANT KIT
K121153
Stryker
Neurology · 151d
Cleared Jun 11, 2012
STRYKER QUIKFLAP STERILE PROCEDURE PACK
K120352
Stryker
Neurology · 126d
Cleared Feb 22, 2012
LEFORTE NEURO SYSTEM BONE PLATE
K112812
Jeil Medical Corporation
Neurology · 148d
Cleared Jan 05, 2012
STRYKER UNIVERSAL NEURO 3 SYSTEM
K112557
Stryker
Neurology · 125d

About Product Code GWO - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code GWO since 1981, with 43 receiving FDA clearance (average review time: 166 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GWO Product Code

FDA review times for GWO submissions have been consistent, averaging 186 days recently vs 165 days historically.

GWO devices are reviewed by the Neurology panel. Browse all Neurology devices →