GWO · Class II · 21 CFR 882.5320

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

Leading manufacturers include Stryker, Osteonic Co., Ltd. and 3D Systems, Inc..

42
Total
42
Cleared
168d
Avg days
1981
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 220d recently vs 165d historically

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

42 devices
1–24 of 42
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 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

About Product Code GWO - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code GWO since 1981, with 42 receiving FDA clearance (average review time: 168 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA Review Time

Recent submissions under GWO have taken an average of 220 days to reach a decision - up from 165 days historically. Manufacturers should account for longer review timelines in current project planning.

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