FDA.reportPublic FDA data

METICULY Patient-specific titanium maxillofacial mesh implant

Primary DI
08859751213144
Brand
METICULY Patient-specific titanium maxillofacial mesh implant
Company
METICULY COMPANY LIMITED
Model
MF-314
Device description
METICULY Patient-specific titanium maxillofacial mesh implant : Facial Mesh XL non-sterile
Published
2024-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232889000METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd.2024-04-30JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18859751213141PackageGS11In Commercial Distribution
08859751213144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1885975121314118859751213141
08859751213144088597512131448859751213144

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.

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
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
08859751216336METICULY Patient-specific titanium mesh implantCP-3032026-03-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809233620106ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620113ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620120ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620137ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620144ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620151ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620168ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620182ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620199ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620205ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620298ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620304ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620311ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620335ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620342ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620366ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620380ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620397ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620403ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620410ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620427ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620489ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620502ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620526ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620533ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620540ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620557ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620625ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620632ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620649ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11