METICULY Patient-specific titanium mesh implant

Primary DI
08859751216336
Brand
METICULY Patient-specific titanium mesh implant
Company
METICULY COMPANY LIMITED
Model
CP-303
Device description
METICULY Patient-specific titanium mesh implant L non-sterile
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252958000METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.2026-01-14GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18859751216333PackageGS11In Commercial Distribution
08859751216336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1885975121633318859751216333
08859751216336088597512163368859751216336

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
661695214
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08859751210556METICULY Patient-specific titanium mesh implantCP-0412026-03-05
08859751210563METICULY Patient-specific titanium mesh implantCP-0422026-03-05
08859751210570METICULY Patient-specific titanium mesh implantCP-0432026-03-05
08859751216206METICULY Patient-specific titanium mesh implantCP-3202026-03-05
08859751216312METICULY Patient-specific titanium mesh implantCP-3012026-03-05
08859751216329METICULY Patient-specific titanium mesh implantCP-3022026-03-05
08859751216343METICULY Patient-specific titanium mesh implantCP-3042026-03-05
08859751216411METICULY Patient-specific titanium mesh implantCP-3212026-03-05
08859751216428METICULY Patient-specific titanium mesh implantCP-3222026-03-05
08859751216435METICULY Patient-specific titanium mesh implantCP-3232026-03-05
08859751216442METICULY Patient-specific titanium mesh implantCP-3242026-03-05
18859751210553METICULY Patient-specific titanium mesh implantCP-0412026-03-05
18859751210560METICULY Patient-specific titanium mesh implantCP-0422026-03-05
18859751210577METICULY Patient-specific titanium mesh implantCP-0432026-03-05
08859751216008METICULY Patient-specific titanium mesh implantCP-3002026-03-05
18859751216203METICULY Patient-specific titanium mesh implantCP-3202026-03-05
18859751216319METICULY Patient-specific titanium mesh implantCP-3012026-03-05
18859751216326METICULY Patient-specific titanium mesh implantCP-3022026-03-05
18859751216333METICULY Patient-specific titanium mesh implantCP-3032026-03-05
18859751216340METICULY Patient-specific titanium mesh implantCP-3042026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859751210556METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210563METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210570METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216206METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216312METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216329METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216343METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216411METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216428METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216435METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216442METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
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