← Back to catalogue

Meticuly

FDA UDI

Class II (US FDA UDI)

by Meticuly Co., Ltd.

Identity

Trade Name
Meticuly FDA UDI
Generic Name
Cranioplasty plate, non-alterable FDA UDI
Device Name
Meticuly’s patient-specific titanium mesh implant is a device designed individually to replace each patient’s bony voids in the cranial and/or craniofacial skeleton. The craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device. FDA UDI
Model / Reference
CP-304 FDA UDI
Description
Meticuly’s patient-specific titanium mesh implant is a device designed individually to replace each patient’s bony voids in the cranial and/or craniofacial skeleton. The craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device. FDA UDI

Identifiers

Primary DI / UDI-DI
08859751216046 FDA UDI
FDA Product Code
GXN FDA UDI
GMDN Term
Cranioplasty plate, non-alterable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cranioplasty plate, non-alterable

Meticuly by Meticuly Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, non-alterable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Meticuly Co., Ltd.

Sources (1)

  • FDA UDI 45ede675-1e11-4dad-b69e-89e20c5f99ad 33 fields · synced May 29, 2026