Product code GXN— Neurology
CustomizedBone Service
- Classification name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Total cleared
- 57
- First cleared
- Most recent
Market context for product code GXN
FDA has cleared devices under product code GXN between 1998 and 2026, filed by 29 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
Top applicants under product code GXN
Adverse events under product code GXN
product code GXN- Injury
- 208
- Total
- 208
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GXN
- K260709 — ClearFit Ti Ring 14mm (171750) +4 more
- K253116 — 3D MAC Titanium Cranial Plate (TCP) System
- K252251 — EASYMADE-TI
- K252958 — METICULY Patient-specific titanium mesh implant
- K243715 — Synthes Patient Specific Implants
- K252573 — KLS Martin Cranial Implants - MR Conditional +6 more
- K240567 — CustomizedBone Service
- K231920 — Longeviti ClearFit OTS Cranial Implant
- K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
- K220357 — MedCAD AccuShape Titanium Patient-Specific Cranial Implant
- K210099 — Meticuly Patient-Specific Titanium Mesh Implant
- K212058 — Longeviti ClearFit OTS Cranial Implants
- K210616 — Longeviti PMMA Static Cranial Implant
- K203349 — Longeviti ClearFit Cranial Implant
- K202901 — Longeviti ClearFit Cranial Implant
- K192702 — DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
- K193547 — CustomizedBone Service
- K191210 — Longeviti ClearFit Cranial Implant
- K180064 — OsteoFab Patient Specific Cranial Device
- K180513 — CustomizedBone Service
- K170410 — Longeviti PMMA Static Cranial Implant
- K171507 — CustomizedBone Service
- K161090 — Cranial PSI
- K160707 — CustomizedBone Service
- K151692 — BioArchitects Patient Specific Cranial/Craniofacial Plate
- K151382 — Patient Contoured Implant-PEEK (PCI-PEEK)
- K130447 — SPEEDY FLAP SYSTEM
- K133082 — OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
- K121818 — OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
- K121755 — CUSTOM CRANIOFACIAL IMPLANT (CCI)
- K122353 — CRAINFIX 2 TITANIUM CLAMP SYSTEM
- K121102 — OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
- K110684 — MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
- K103582 — KELYNIAM CUSTOM SKULL IMPLANT (CSI)
- K082175 — MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
- K072707 — PATIENT CONTOURED MESH-PEEK (PCM-P)
- K070901 — MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K062819 — BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K062857 — KLS MARTIN QUICK DISC
- K062570 — PATIENT CONTOURED MESH (PCM)
- K052871 — STRYKER CUSTOM TI IMPLANT
- K053199 — SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
- K033868 — SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
- K040864 — CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
- K031034 — SPIN DOWN RAPIDFLAP
- K022277 — OSTEOMED CRANIAL FLAP FIXATION SYSTEM
- K030378 — STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
- K020088 — MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K013050 — THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K013000 — MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
- K993990 — LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
- K991860 — SYNTHES CRANIAL FLAP TWIST CLAMP
- K992000 — SYNTHES CRANIAL FLAP TUBE CLAMP
- K991029 — RAPIDFLAP CRANIAL CLAMP
- K971252 — SEVRAIN CRANIAL CLAMP
- K971408 — SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
- K972332 — AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.