FDA 510(k) Applications for Medical Device Product Code "GXN"
(Plate, Cranioplasty, Preformed, Non-Alterable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K040864 | AESCULAP | CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM | 06/17/2004 |
| K972332 | AESCULAP, INC. | AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM | 01/16/1998 |
| K122353 | AESCULAP, INC. | CRAINFIX 2 TITANIUM CLAMP SYSTEM | 08/30/2012 |
| K151692 | BioArchitects USA, LLC | BioArchitects Patient Specific Cranial/Craniofacial Plate | 11/20/2015 |
| K062819 | BIOPLATE, INC. | BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 12/04/2006 |
| K020088 | BIOPLATE, INC. | MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | 02/08/2002 |
| K070901 | BIOPLATE, INC. | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | 06/15/2007 |
| K082175 | BIOPLATE, INC. | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION | 08/13/2008 |
| K013050 | BIOPLATE, INC. | THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | 12/10/2001 |
| K180513 | Fin-Ceramica Faenza S.p.A | CustomizedBone Service | 05/15/2018 |
| K160707 | FIN-CERAMICA FAENZA SPA | CustomizedBone Service | 12/17/2016 |
| K171507 | Fin-ceramica faenza spa | CustomizedBone Service | 09/01/2017 |
| K193547 | Fin-Ceramica Faenza Spa | CustomizedBone Service | 01/17/2020 |
| K971252 | IKONOS CORP. | SEVRAIN CRANIAL CLAMP | 07/06/1998 |
| K971408 | IKONOS CORP. | SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) | 05/12/1998 |
| K130447 | Jeil Medical Corporation | SPEEDY FLAP SYSTEM | 12/22/2014 |
| K103582 | KELYNIAM GLOBAL, INC | KELYNIAM CUSTOM SKULL IMPLANT (CSI) | 04/14/2011 |
| K121755 | KELYNIAM GLOBAL, INC. | CUSTOM CRANIOFACIAL IMPLANT (CCI) | 09/25/2012 |
| K062857 | KLS MARTIN L.P. | KLS MARTIN QUICK DISC | 11/22/2006 |
| K151382 | KLS MARTIN L.P. | Patient Contoured Implant-PEEK (PCI-PEEK) | 11/09/2015 |
| K062570 | KLS-MARTIN L.P. | PATIENT CONTOURED MESH (PCM) | 10/31/2006 |
| K072707 | KLS-MARTIN L.P. | PATIENT CONTOURED MESH-PEEK (PCM-P) | 12/19/2007 |
| K214109 | Kontour(XiÆan) Medical Technology Co., Ltd. | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | 10/28/2022 |
| K191210 | Longeviti Neuro Solutions, LLC | Longeviti ClearFit Cranial Implant | 01/09/2020 |
| K202901 | Longeviti Neuro Solutions, LLC | Longeviti ClearFit Cranial Implant | 10/30/2020 |
| K203349 | Longeviti Neuro Solutions, LLC | Longeviti ClearFit Cranial Implant | 12/16/2020 |
| K212058 | Longeviti Neuro Solutions, LLC | Longeviti ClearFitÖ OTS Cranial Implants | 09/08/2021 |
| K210616 | Longeviti Neuro Solutions, LLC | Longeviti PMMA Static Cranial Implant | 03/31/2021 |
| K170410 | Longeviti Neuro Solutions, LLC | Longeviti PMMA Static Cranial Implant | 03/23/2018 |
| K220357 | MedCAD | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | 08/26/2022 |
| K013000 | MEDTRONIC NEUROSURGERY | MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 | 12/05/2001 |
| K210099 | Meticuly Co., Ltd. | Meticuly Patient-Specific Titanium Mesh Implant | 12/21/2021 |
| K161090 | OSSDSIGN AB | Cranial PSI | 01/19/2017 |
| K022277 | OSTEOMED CORP. | OSTEOMED CRANIAL FLAP FIXATION SYSTEM | 04/01/2003 |
| K133082 | OSTEOSYMBIONICS, LLC | OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE | 05/20/2014 |
| K121102 | OSTEOSYMBIONICS, LLC | OSTEOSYMBIONICS PEEK CRANIAL IMPLANT | 08/08/2012 |
| K121818 | OXFORD PERFORMANCE MATERIALS | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE | 02/07/2013 |
| K180064 | Oxford Performance Materials, Inc. | OsteoFab Patient Specific Cranial Device | 07/27/2018 |
| K993990 | STRYKER INSTRUMENTS | LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM | 02/22/2000 |
| K030378 | STRYKER INSTRUMENTS | STRYKER LEIBINGER CRANIAL FIXATION SYSTEM | 03/20/2003 |
| K052871 | STRYKER LEIBINGER | STRYKER CUSTOM TI IMPLANT | 12/16/2005 |
| K033868 | SYNTHES (USA) | SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS | 06/21/2004 |
| K992000 | SYNTHES (USA) | SYNTHES CRANIAL FLAP TUBE CLAMP | 07/20/1999 |
| K991860 | SYNTHES (USA) | SYNTHES CRANIAL FLAP TWIST CLAMP | 07/20/1999 |
| K053199 | SYNTHES (USA) | SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT | 12/14/2005 |
| K192702 | Synthes (USA) Products LLC | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | 09/18/2020 |
| K110684 | VANDUZEN DBA MEDCAD | MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT | 06/24/2011 |
| K991029 | WALTER LORENZ SURGICAL, INC. | RAPIDFLAP CRANIAL CLAMP | 04/23/1999 |
| K031034 | WALTER LORENZ SURGICAL, INC. | SPIN DOWN RAPIDFLAP | 05/21/2003 |
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