FDA Product Code
FDA Product Code GXN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5330
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) | Longeviti Neuro Solutions | 2026-06-25 | Traditional | PDF ↗ |
| K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | 2026-06-18 | Traditional | PDF ↗ |
| K252251 | EASYMADE-TI | CG Bio Co., Ltd. | 2026-04-09 | Traditional | PDF ↗ |
| K252958 | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | 2026-01-14 | Traditional | PDF ↗ |
| K243715 | Synthes Patient Specific Implants | Synthes GmbH | 2025-11-12 | Traditional | PDF ↗ |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | KLS-Martin L.P. | 2025-11-10 | Traditional | PDF ↗ |
| K240567 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2024-03-28 | Special | PDF ↗ |
| K231920 | Longeviti ClearFit OTS Cranial Implant | Longeviti Neuro Solutions, LLC | 2023-11-09 | Special | PDF ↗ |
| K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour(XiAn) Medical Technology Co., Ltd. | 2022-10-28 | Traditional | PDF ↗ |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | Medcad | 2022-08-26 | Traditional | PDF ↗ |
| K210099 | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | 2021-12-21 | Traditional | PDF ↗ |
| K212058 | Longeviti ClearFit OTS Cranial Implants | Longeviti Neuro Solutions, LLC | 2021-09-08 | Traditional | PDF ↗ |
| K210616 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | 2021-03-31 | Special | PDF ↗ |
| K203349 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-12-16 | Special | PDF ↗ |
| K202901 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-10-30 | Special | PDF ↗ |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | 2020-09-18 | Traditional | PDF ↗ |
| K193547 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2020-01-17 | Special | PDF ↗ |
| K191210 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-01-09 | Traditional | PDF ↗ |
| K180064 | OsteoFab Patient Specific Cranial Device | Oxford Performance Materials, Inc. | 2018-07-27 | Traditional | PDF ↗ |
| K180513 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2018-05-15 | Traditional | PDF ↗ |
| K170410 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | 2018-03-23 | Traditional | PDF ↗ |
| K171507 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2017-09-01 | Traditional | PDF ↗ |
| K161090 | Cranial PSI | Ossdsign AB | 2017-01-19 | Traditional | PDF ↗ |
| K160707 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2016-12-17 | Traditional | PDF ↗ |
| K151692 | BioArchitects Patient Specific Cranial/Craniofacial Plate | Bioarchitects USA, LLC | 2015-11-20 | Traditional | PDF ↗ |
| K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | KLS Martin L.P. | 2015-11-09 | Traditional | PDF ↗ |
| K130447 | SPEEDY FLAP SYSTEM | Jeil Medical Corporation | 2014-12-22 | Traditional | PDF ↗ |
| K133082 | OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE | Osteosymbionics, LLC | 2014-05-20 | Traditional | PDF ↗ |
| K121818 | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE | Oxford Performance Materials | 2013-02-07 | Traditional | PDF ↗ |
| K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) | Kelyniam Global, Inc. | 2012-09-25 | Traditional | PDF ↗ |
| K122353 | CRAINFIX 2 TITANIUM CLAMP SYSTEM | Aesculap, Inc. | 2012-08-30 | Special | PDF ↗ |
| K121102 | OSTEOSYMBIONICS PEEK CRANIAL IMPLANT | Osteosymbionics, LLC | 2012-08-08 | Traditional | PDF ↗ |
| K110684 | MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT | Vanduzen Dba Medcad | 2011-06-24 | Traditional | PDF ↗ |
| K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) | Kelyniam Global, Inc. | 2011-04-14 | Traditional | PDF ↗ |
| K082175 | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION | Bioplate, Inc. | 2008-08-13 | Special | PDF ↗ |
| K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) | KLS-Martin L.P. | 2007-12-19 | Traditional | PDF ↗ |
| K070901 | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2007-06-15 | Special | PDF ↗ |
| K062819 | BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | 2006-12-04 | Traditional | PDF ↗ |
| K062857 | KLS MARTIN QUICK DISC | KLS Martin L.P. | 2006-11-22 | Traditional | PDF ↗ |
| K062570 | PATIENT CONTOURED MESH (PCM) | KLS-Martin L.P. | 2006-10-31 | Traditional | PDF ↗ |
| K052871 | STRYKER CUSTOM TI IMPLANT | Stryker Leibinger | 2005-12-16 | Traditional | PDF ↗ |
| K053199 | SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT | Synthes (Usa) | 2005-12-14 | Special | PDF ↗ |
| K033868 | SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS | Synthes (Usa) | 2004-06-21 | Traditional | PDF ↗ |
| K040864 | CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM | Aesculap | 2004-06-17 | Traditional | PDF ↗ |
| K031034 | SPIN DOWN RAPIDFLAP | Walter Lorenz Surgical, Inc. | 2003-05-21 | Special | PDF ↗ |
| K022277 | OSTEOMED CRANIAL FLAP FIXATION SYSTEM | Osteomed Corp. | 2003-04-01 | Traditional | PDF ↗ |
| K030378 | STRYKER LEIBINGER CRANIAL FIXATION SYSTEM | Stryker Instruments | 2003-03-20 | Traditional | PDF ↗ |
| K020088 | MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2002-02-08 | Special | PDF ↗ |
| K013050 | THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2001-12-10 | Traditional | PDF ↗ |
| K013000 | MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 | Medtronic Neurosurgery | 2001-12-05 | Traditional | PDF ↗ |
| K993990 | LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM | Stryker Instruments | 2000-02-22 | Traditional | PDF ↗ |
| K991860 | SYNTHES CRANIAL FLAP TWIST CLAMP | Synthes (Usa) | 1999-07-20 | Traditional | PDF ↗ |
| K992000 | SYNTHES CRANIAL FLAP TUBE CLAMP | Synthes (Usa) | 1999-07-20 | Traditional | PDF ↗ |
| K991029 | RAPIDFLAP CRANIAL CLAMP | Walter Lorenz Surgical, Inc. | 1999-04-23 | Special | PDF ↗ |
| K971252 | SEVRAIN CRANIAL CLAMP | Ikonos Corp. | 1998-07-06 | Traditional | PDF ↗ |
| K971408 | SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) | Ikonos Corp. | 1998-05-12 | Traditional | PDF ↗ |
| K972332 | AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM | Aesculap, Inc. | 1998-01-16 | Traditional | PDF ↗ |
Product code GXN · Class II · Neurology. Data: openFDA.