FDA.report

METICULY Patient-specific titanium mesh implant

Primary DI
18859751216319
Brand
METICULY Patient-specific titanium mesh implant
Company
METICULY COMPANY LIMITED
Model
CP-301
Device description
METICULY Patient-specific titanium mesh implant S non-sterile
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications

CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions

SubmissionSupplement
K252958000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18859751216319PackageGS11In Commercial Distribution
08859751216312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1885975121631918859751216319
08859751216312088597512163128859751216312

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
661695214
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
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
18859751216418METICULY Patient-specific titanium mesh implantCP-3212026-03-05
18859751216425METICULY Patient-specific titanium mesh implantCP-3222026-03-05
18859751216432METICULY Patient-specific titanium mesh implantCP-3232026-03-05
18859751216449METICULY Patient-specific titanium mesh implantCP-3242026-03-05
18859751212113METICULY Patient-specific titanium maxillofacial mesh implantMF-2112024-07-31
18859751212120METICULY Patient-specific titanium maxillofacial mesh implantMF-2122024-07-31
18859751213110METICULY Patient-specific titanium maxillofacial mesh implantMF-3112024-07-31
18859751213127METICULY Patient-specific titanium maxillofacial mesh implantMF-3122024-07-31
18859751213134METICULY Patient-specific titanium maxillofacial mesh implantMF-3132024-07-31
18859751213141METICULY Patient-specific titanium maxillofacial mesh implantMF-3142024-07-31
08859751212130MeticulyMF-2132023-11-17
08859751216039MeticulyCP-3032023-11-08

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