FDA Product Code GWO: Plate, Cranioplasty, Preformed, Alterable
Leading manufacturers include Stryker and Osteonic Co., Ltd..
2
Total
2
Cleared
239d
Avg days
2021
Since
List of Plate, Cranioplasty, Preformed, Alterable devices cleared through 510(k)
2 devices
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)
Osteonic Co., Ltd.
Neurology
353d
Cleared
Feb 09, 2021
Stryker PEEK Customized Cranial Implant Kit
Stryker
Neurology
124d
How to use this database
This page lists all FDA 510(k) submissions for Plate, Cranioplasty, Preformed, Alterable devices (product code GWO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Neurology FDA review panel. Browse all Neurology devices →