FDA.reportPublic FDA data

Meticuly

Primary DI
08859751216015
Brand
Meticuly
Company
METICULY COMPANY LIMITED
Model
CP-301
Device 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.
Published
2023-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18859751216012PackageGS11In Commercial Distribution
08859751216015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1885975121601218859751216012
08859751216015088597512160158859751216015

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
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 DI, Brand, Model table
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810188323873HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
00810125929274KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-23
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00810188323552HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-23
00810188323859HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-23
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00810125929267KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810188323828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-20
00810188323811HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-19
00810188323835HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-19
00810188323750HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-17
00810125929168KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
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00810125929199KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929205KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929212KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810188323712HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323736HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323743HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13