GXN · Plate, Cranioplasty, Preformed, Non-Alterable

Neurology · 21 CFR 882.5330 · Class 2

Overview

Product CodeGXN
Device NamePlate, Cranioplasty, Preformed, Non-Alterable
Regulation21 CFR 882.5330
Device ClassClass 2
Review PanelNeurology
ImplantYes

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 55)

Showing 20 most recent of 55 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K252251EASYMADE-TICG Bio Co., Ltd.Apr 9, 2026SESE
K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.Jan 14, 2026SESE
K243715Synthes Patient Specific ImplantsSynthes GmbHNov 12, 2025SESE
K252573KLS 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) - STERILEKLS-Martin L.P.Nov 10, 2025SESE
K240567CustomizedBone ServiceFin-Ceramica Faenza S.P.A.Mar 28, 2024SESE
K231920Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLCNov 9, 2023SESE
K214109PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)Kontour(Xi’An) Medical Technology Co., Ltd.Oct 28, 2022SESE
K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcadAug 26, 2022SESE
K210099Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd.Dec 21, 2021SESE
K212058Longeviti ClearFit™ OTS Cranial ImplantsLongeviti Neuro Solutions, LLCSep 8, 2021SESE
K210616Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLCMar 31, 2021SESE
K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLCDec 16, 2020SESE
K202901Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLCOct 30, 2020SESE
K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLCSep 18, 2020SESE
K193547CustomizedBone ServiceFin-Ceramica Faenza S.P.A.Jan 17, 2020SESE
K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLCJan 9, 2020SESE
K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.Jul 27, 2018SESE
K180513CustomizedBone ServiceFin-Ceramica Faenza S.P.A.May 15, 2018SESE
K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLCMar 23, 2018SESE
K171507CustomizedBone ServiceFin-Ceramica Faenza S.P.A.Sep 1, 2017SESE

Top Applicants

Innolitics

Panel 1

/
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...