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.

44
Total
44
Cleared
163d
Avg days
1981
Since
44 devices
25–44 of 44
Cleared Oct 17, 2013
UNIVERSAL NEURO 3 SYSTEM
K131775
Stryker
Neurology · 122d
Cleared Sep 05, 2013
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
K123723
Synthes
Neurology · 275d
Cleared Apr 05, 2013
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
K122049
Kinamed, Inc.
Neurology · 267d
Cleared Jan 17, 2013
RESORB-X G
K121606
KLS-Martin L.P.
Neurology · 230d
Cleared Oct 12, 2012
BIOMET MICROFIXATION NEURO PLATING SYSTEM
K121624
Biomet Microfixation
Neurology · 133d
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
Cleared Aug 15, 2011
OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
K111176
Osteomed LP
Neurology · 110d
Cleared Jul 14, 2011
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
K111065
Howmedica Osteonics Corp. Dba Stryker Orthopeadics
General & Plastic Surgery · 87d
Cleared Dec 13, 2010
FRONTIER DEVICES NEURO SYSTEM
K100205
Folsom Metal Products, Inc.
Neurology · 322d
Cleared May 29, 2008
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
K073006
Takiron Co., Ltd.
Neurology · 218d
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 Feb 21, 1991
TITANIUM MESH
K903485
Ruggles Corp.
Neurology · 205d
Cleared Oct 14, 1986
NEUROSCOPE SEEG
K861884
Siegen Corp.
Neurology · 152d
Cleared Jul 11, 1986
MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
K861822
Valley Forge Scientific Corp.
Neurology · 60d
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