GWO · Class II · 21 CFR 882.5320

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

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

43
Total
43
Cleared
166d
Avg days
1981
Since
43 devices
25–43 of 43
Cleared Dec 18, 2007
SYNTHES (USA) 2.0MM TITANIUM T-PLATE
K072758
Synthes (Usa)
Neurology · 81d
Cleared Mar 16, 1998
SYNTHES CRANIAL SPRING CLIP (CSC)
K974206
Synthes (Usa)
Neurology · 126d
Cleared Nov 06, 1981
RION AUDIOMETER AA-67
K812951
Rion Acoustic Instruments, Inc.
Neurology · 16d
Cleared Nov 06, 1981
RION AUDIOMETER AA-68
K812952
Rion Acoustic Instruments, Inc.
Neurology · 16d