GXN · Class II · 21 CFR 882.5330

FDA Product Code GXN: Plate, Cranioplasty, Preformed, Non-alterable

Leading manufacturers include Longeviti Neuro Solutions, LLC, KLS-Martin L.P. and Fin-Ceramica Faenza S.P.A..

57
Total
57
Cleared
155d
Avg days
1998
Since
57 devices
25–48 of 57
Cleared Nov 20, 2015
BioArchitects Patient Specific Cranial/Craniofacial Plate
K151692
Bioarchitects USA, LLC
Neurology · 150d
Cleared Nov 09, 2015
Patient Contoured Implant-PEEK (PCI-PEEK)
K151382
KLS-Martin L.P.
Neurology · 171d
Cleared Dec 22, 2014
SPEEDY FLAP SYSTEM
K130447
Jeil Medical Corporation
Neurology · 669d
Cleared May 20, 2014
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
K133082
Osteosymbionics, LLC
Neurology · 232d
Cleared Feb 07, 2013
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
K121818
Oxford Performance Materials
Neurology · 232d
Cleared Sep 25, 2012
CUSTOM CRANIOFACIAL IMPLANT (CCI)
K121755
Kelyniam Global, Inc.
Neurology · 102d
Cleared Aug 30, 2012
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353
Aesculap, Inc.
Neurology · 27d
Cleared Aug 08, 2012
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
K121102
Osteosymbionics, LLC
Neurology · 119d
Cleared Jun 24, 2011
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
K110684
Vanduzen Dba Medcad
Neurology · 105d
Cleared Apr 14, 2011
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
K103582
Kelyniam Global, Inc.
Neurology · 127d
Cleared Aug 13, 2008
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
K082175
Bioplate, Inc.
Neurology · 12d
Cleared Dec 19, 2007
PATIENT CONTOURED MESH-PEEK (PCM-P)
K072707
KLS-Martin L.P.
Neurology · 85d
Cleared Jun 15, 2007
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K070901
Bioplate, Inc.
Neurology · 74d
Cleared Dec 04, 2006
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K062819
Bioplate, Inc.
Neurology · 75d
Cleared Nov 22, 2006
KLS MARTIN QUICK DISC
K062857
KLS-Martin L.P.
Neurology · 58d
Cleared Oct 31, 2006
PATIENT CONTOURED MESH (PCM)
K062570
KLS-Martin L.P.
Neurology · 61d
Cleared Dec 14, 2005
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199
Synthes (Usa)
Neurology · 28d
Cleared Jun 21, 2004
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868
Synthes (Usa)
Neurology · 192d
Cleared May 21, 2003
SPIN DOWN RAPIDFLAP
K031034
Walter Lorenz Surgical, Inc.
Neurology · 50d
Cleared Apr 01, 2003
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
K022277
Osteomed Corp.
Neurology · 260d
Cleared Mar 20, 2003
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378
Stryker Instruments
Neurology · 43d
Cleared Feb 08, 2002
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K020088
Bioplate, Inc.
Neurology · 29d
Cleared Dec 10, 2001
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K013050
Bioplate, Inc.
Neurology · 90d
Cleared Dec 05, 2001
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
K013000
Medtronic Neurosurgery
Neurology · 90d