FDA.reportPublic FDA data

510(k) K210099

Device
Meticuly Patient-Specific Titanium Mesh Implant
Applicant
Meticuly Co., Ltd.
510(k) number
K210099
Product code
GXN
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-21
Date received
2021-01-14
Regulation
882.5330
Classification name
Plate, Cranioplasty, Preformed, Non-Alterable
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Peeranoot Lohwongwatana
Address
32/77, Soi Samakkee 58/20, Samakkee Rd., Tasai Muang Nonthaburi TH 11000 11000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252251EASYMADE-TICG Bio Co., Ltd.2026-04-09
K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.2026-01-14
K243715Synthes Patient Specific ImplantsSynthes GmbH2025-11-12
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.2025-11-10
K240567CustomizedBone ServiceFin-Ceramica Faenza S.P.A.2024-03-28
K231920Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC2023-11-09
K214109PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)Kontour(Xi’An) Medical Technology Co., Ltd.2022-10-28
K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad2022-08-26
K212058Longeviti ClearFit™ OTS Cranial ImplantsLongeviti Neuro Solutions, LLC2021-09-08
K210616Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC2021-03-31
K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC2020-12-16
K202901Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC2020-10-30
K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC2020-09-18
K193547CustomizedBone ServiceFin-Ceramica Faenza S.P.A.2020-01-17
K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC2020-01-09